ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) 111 Diabetic Retinopathy-Clinical Research I Purpose: To compare the effect of an intravitreal injection of bevacizumab alone Sunday, May 6, 2012, 8:30 AM - 10:15 AM (IVB) or combined with triamcinolone (IVB/IVT) versus triamcinolone (IVT) in Hall B/C Poster Session patients with diabetic macular edema (DME). Program #/Board # Range: 344-377/D895-D928 Methods: In this randomized three-arm clinical trial, eligible eyes were assigned Organizing Section: Retina+ randomly to one of the three study arms; the IVB group, two injections of 1.25 mg Contributing Section(s): Visual Neurophysiology of bevacizumab with 6-week intervals; the IVB/IVT group, 1.25 mg of intravitreal bevacizumab with 2 mg of intravitreal triamcinolone; and the IVT group, 2 mg of intravitreal triamcinolone. The clinical course of best-corrected visual acuity and Program Number: 344 Poster Board Number: D895 central macular thickness by optical coherence tomography was monitored for up Presentation Time: 8:30 AM - 10:15 AM to12 months after initial injection. Intraocular Pressure in Diabetic Patients Nahoko Ogata1, Kayako Matsuyama2, Masato Matsuoka2, Tadanobu Yoshikawa2, Results: One hundred eleven eyes of 105 patients with DME completed 12 months Kanji Takahashi3. 1Ophthalmology, Nara Medical University, Kashikhara, Japan; of follow-up. The IVB/IVT group and the IVT group showed better visual acuity 2Ophthalmology, Kansai Medical University, Moriguchi, Japan; 3Ophthalmology, and reduced central macular thickness at 6 weeks and 3 months, compared with the IVB group (P=0.041, P=0.02 at 6 weeks; P=0.045, P=0.043 at 3 months, Kansai Medical University, Hirakata, Japan. respectively). However, no significant difference in visual acuity and central Purpose: Several cross sectional studies have found a positive and significant macular thickness was observed between the three groups at 12 months (P=0.088, correlation between diabetes and primary open-angle glaucoma (OAG). However, P=0.132, respectively). The frequency of retreatment was lower in the IVB/IVT there have been other studies that failed to confirm this significant association. and IVT groups during the12-month period (P < 0.001). No significant differences Thus, the relationship between DM and OAG has not been clearly established. The in visual acuity or central macular thickness were observed between the IVB/IVT purpose of this study is to determine whether the intraocular pressure (IOP) in and IVT groups during follow-up. diabetic patients is significantly different from that of non-diabetic patients. Conclusions: IVB/IVT and IVT showed more pronounced effects during the Methods: Seven hundred and sixteen patients who were >20 years and did not earlier post-injection period. However, levels of visual acuity or central macular have any type of glaucoma were studied. The medical records of the first visiting of thickness at 12 months were comparable in the three study groups. No beneficial all patients were initially examined. At the initial examination, each patient had a effect of the combination injection was observed. detailed interview and comprehensive ophthalmic examinations. The data were Commercial Relationships: Minchul Shin, None; Hyokyoung Lee, None; Jiwon analyzed statistically using the Mann-Whitney test, one way analysis of variance Lim, None (ANOVA) with Dunnet’s correction, and Pearson's product moment correlation Support: None coefficient (r). Clinical Trial: http://www.clinicaltrials.gov, NCT01342159 Results: The mean IOP of the diabetic patients was 15.9 ± 0.4 mmHg (mean ± SEM, n=219) which was significantly higher than the 14.0 ± 0.1 mmHg (n = 497) in the non-diabetic patients (P < 0.0001). The IOP was negatively correlated with Program Number: 347 Poster Board Number: D898 the age (r = -0.213; P = 0.016) in the diabetic patients and it was weakly but Presentation Time: 8:30 AM - 10:15 AM significantly correlated with the level of HbA1c (r = 0.240; P = 0.015) in the A Prospective Randomized Trial Of Intravitreal Bevacizumab Versus diabetic retinopathy group. Ranibizumab For The Management Of Refractory Diabetic Macular Edema Conclusions: he significantly higher IOP in diabetic patients and the positive Rodrigo Jorge1, Antonio B. Nepomuceno1, Erika Takaki1, Jefferson A. RIbeiro1, correlation of the IOP with the level of HbA1c in patients with diabetic retinopathy Renato Peroni2, Ingrid U. Scott3, Jose A. Cardillo2, Andre Messias1. indicate that the IOP in diabetic patients should be carefully monitored especially 1Ophthalmology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao those with poor control of the level of the HbA1c. Preto, Brazil; 2Ophthalmology, Hospital de Olhos de Araraquara, Araraquara, Commercial Relationships: Nahoko Ogata, None; Kayako Matsuyama, Brazil; 3Ophthalmology & Public Health Sciences, Penn State College of Medicine, None; Masato Matsuoka, None; Tadanobu Yoshikawa, None; Kanji Takahashi, Hershey, PA. None Purpose: To compare anatomic and visual acuity outcomes associated with Support: None intravitreal bevacizumab (IVB) versus ranibizumab (IVR) for the management of refractory diabetic macular edema (DME). Methods: Forty-seven patients (63 eyes) with refractory center-involving DME Program Number: 345 Poster Board Number: D896 were randomly assigned to receive either 1.5 mg/0.06 cc IVB or 0.5 mg/0.05 cc Presentation Time: 8:30 AM - 10:15 AM IVR. Intravitreal injections were performed at baseline and monthly if central Retinal Vascular Caliber Changes on OCT after Intravitreal Bevacizumab subfield thickness (CSFT) measured by spectral domain optical coherence Injection in Diabetic Macular Edema tomography (SDOCT) > 275 um. Comprehensive ophthalmological examination Sung Soo Kim, Hyeong Eun Kim. Ophthalmology, Yonsei Univ Gangnam Sev was performed monthly, including SDOCT and Early Treatment Diabetic Hosp, Seoul, Republic of Korea. Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) measurement. Purpose: To investigate retinal vascular caliber changes with Spectral Domain Results: To date, 73% and 56% of the patients completed 24 and 48 weeks of OCT after intravitreal Bevacizumab injection in diabetic macular edema patients follow-up, respectively. A statistically significant reduction in mean CSFT was Methods: 34 eyes of 29 diabetic macular edema patients who were injected observed for the IVB and IVR groups at all study visits compared to baseline Bevacizumab(1.25g/0.05ml) intravitreously were studied. 24 fellow eyes of 24 (p<0.05). Mean ± SE CSFT (µm) was 451.7 ± 22.3 and 322.1 ± 17.6, (56% < 275 patients with Bevacizumab injection were also recruited as a control group. We µm) for IVB, and 421.9 ± 23.1 and 284.9 ± 16.5, (76% < 275 µm) for IVR, at measured retinal vascular caliber at 0.5~1 disc size apart from disc margin with baseline and week 48, respectively. There was no significant difference in CSFT Spectral Domain OCT at the baseline, 1 month and 3 months follow-up visits. reduction between the IVB and IVR groups at any study visit. A significant Central macular thicknesses were also measured. improvement in mean BCVA was observed within each of the two study groups at Results: Over the 3 months of studies, there was a significant reduction of all study visits compared to baseline (p<0.05); mean ± SE BCVA (logMAR) was arteriolar caliber at 3 months compared to baseline (p=0.024), There were 0.60 ± 0.05 and 0.39 ± 0.07 for IVB, and 0.63 ± 0.05 and 0.42 ± 0.06 for IVR, at significant reduction of venular caliber at 1 month(p=0.001) and 3 baseline and week 48, respectively. There was no significant difference in BCVA months(p=0.000) compared to baseline. Venymliular caliber reduction at 3 months improvement between the IVB and IVR groups at any study visit. No significant follow-up was significantly correlated with central macular thickness(R=0.487, change in intraocular pressure change was observed in either group during follow- p=0.003). up. One patient developed endophthalmitis after his first ranibizumab injection. Conclusions: Retinal venular caliber reduction was significant at 1 and 3 months Conclusions: These data indicate that IVB and IVR are associated with similar follow-up and arteriolar caliber reduction was significant at 3 months follow-up effects on CSFT and BCVA at 1 year in patients with refractory DME. compared to baseline. After 3 months of treatment, venular caliber reduction was Commercial Relationships: Rodrigo Jorge, None; Antonio B. Nepomuceno, correlated with reduction of central macular thickness. None; Erika Takaki, None; Jefferson A. RIbeiro, None; Renato Peroni, Commercial Relationships: Sung Soo Kim, None; Hyeong Eun Kim, None None; Ingrid U. Scott, None; Jose A. Cardillo, None; Andre Messias, None Support: None Support: FAPESP 2010/16980-6 Clinical Trial: Comitê de Ética em Pesquisa - Hospital das Clínicas da Faculdade Program Number: 346 Poster Board Number: D897 de Medicina de Ribeirão Preto Presentation Time: 8:30 AM - 10:15 AM http://www.hcrp.fmrp.usp.br/sitehc/informacao.aspx?id=64&ref=4&refV=27, Comparison Of Intravitreal Bevacizumab Alone Or Combined With 13368/2010 Triamcinolone Versus Triamcinolone In Diabetic Macular Edema: A Randomized Clinical Trial Minchul Shin, Hyokyoung Lee, Jiwon Lim. Ophthalmology, Chunchon Sacred Heart Hospital, Hallym University, Chuncheon-Si, Gangwon-Do, Republic of Korea. Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) Program Number: 348 Poster Board Number: D899 Clinical Trial: http://www.clinicaltrials.gov, NCT01486238 Presentation Time: 8:30 AM - 10:15 AM Visual Acuity after 3 Intial Injections of Intravitreal Ranibizumab in the Program Number: 350 Poster Board Number: D901 Management of Diabetic Macular Edema Presentation Time: 8:30 AM - 10:15 AM Claus Zehetner1, Martina T. Kralinger2, Gerhard F. Kieselbach3. 1Ophthalmology, Maculopexy: A New Treatment for Diffuse Diabetic Macular Edema Medical University Innsbruck, Innsbruck, Austria; 2Ophthalmology, Medical Robert E. Morris, Matthew H. Oltmanns, Gregory M. Lewis. Retina Spec of University of Innsbruck, Innsbruck, Austria; 3Ophthalmology, University of Alabama, LLC, Birmingham, AL. Innsbruck, Innsbruck, Austria. Purpose: To determine the safety and efficacy of maculopexy (the production of Purpose: To determine change of best corrected visual acuity (BCVA) and microscopic chorioretinal adhesions by grid laser treatment together with gas anatomic effects of 3 initial intravitreal injections of ranibizumab followed by a pro tamponade) combined with intravitreal triamcinolone acetate (combined assisted re nata (PRN) dosing regimen in patients with clinically significant diabetic maculopexy, CAMP) to permanently increase retinal resistance to expansion as a macular edema (CSME). new treatment for diffuse diabetic macular edema (DDME). Methods: 15 eyes of 9 patients (mean age, 67,1 years [range, 41-78]) with center- Methods: Retrospective, consecutive case series of 10 eyes of 10 patients with involving CSME were treated with 3 monthly intravitreal injections of 0,5 mg DDME that did not have foveal ischemia, all treated by CAMP. ranibizumab followed by a PRN reinjection regimen. Follow-up in all patients was Results: Visual acuity improved significantly (0.43 (20/54) to 0.26 (20/36) 6 months. logMAR (Snellen), p=0.04) as did optical coherence tomography (OCT) central Analysis included the mean change from baseline BCVA and change from baseline thickness (433 to 220 uM, p=0.0002). Mean length of follow-up was 43.6 months mean foveal thickness (FTH) defined as center subfield thickness. (range 8-72). Five patients (50%) had 2 or more Snellen lines of improvement, 2 Reinjections after week 12 were performed upon signs of disease activity as had 1 line of improvement and 3 remained unchanged. Eight of 8 eyes (100%) with defined by increase of mean foveal thickness (FTH) determined by SD OCT or loss foveal cysts had resolution of the cysts with concave fovea at final follow-up. of best-corrected visual acuity (BCVA). Conclusions: CAMP appears to be a safe and effective new treatment for DDME, Results: The baseline mean BCVA was 0,32±0,22 and the mean FTH was a common and visually debilitating condition that has heretofore had no 505±210 μm. Mean HbA1c was 6,4±0,4. At month 3 after 3 intravitreal injections satisfactory treatment. A larger prospective clinical trial is justified based on of ranibizumab mean BCVA was 0,38±0,21 (p=1,0) and mean FTH was 333±135 encouraging results of this pilot study. μm (p=0,139). At month 6 mean BCVA was 0,31±0,21 (p=1,0) and mean FTH was Commercial Relationships: Robert E. Morris, None; Matthew H. Oltmanns, 385±143 μm (p=0,019). The mean number of reinjections between month 4 and 6 None; Gregory M. Lewis, None was 0,43±0,51 resulting in a mean total of 3,43±0,51 injections per study eye. None Support: None of the study eyes received more than 1 reinjection and 60% of all study eyes only received the initial 3 injections of ranibizumab. Conclusions: In this series a regimen with 3 initial intravitreal injections of Program Number: 351 Poster Board Number: D902 ranibizumab followed by PRN reinjections resulted in overall stabilization of Presentation Time: 8:30 AM - 10:15 AM BCVA. Despite a favorable morphological response as shown by reduction of Reversal Of Diabetic Macular Edema Following Gastric Bypass Surgery mean FTH no statistically significant gain in BCVA could be achieved. Bernard J. Fowler. Ophthalmology, Englewood Hospital & Medical Center, This may indicate that a PRN regimen does not prove an equivalent alternative to a Englewood, NJ. fixed-dosing schedule in the treatment of diabetic macular edema. Purpose: To demonstrate connection between complete reversal of diabetic Commercial Relationships: Claus Zehetner, None; Martina T. Kralinger, macular edema{which had been previously resistant to standard laser therapy} and None; Gerhard F. Kieselbach, None gastric bypass surgery in an obese Type 2 diabetic. Support: None Methods: The patient was followed at regular intervals using visual acuity OCT and dilated retinal exam following gastric bypass surgery. Results: Complete resolution of diabetic macular edema in both eyes. HgbA1c and Program Number: 349 Poster Board Number: D900 serum lipemic studies normalized. Hypertension normalized. Patient is off all Presentation Time: 8:30 AM - 10:15 AM diabetic and antihypertensive medications.Weight loss was 55 lbs. Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease Conclusions: Gastric bypass can relieve severe sight threatening ocular (PRESerVe) Study complications in obese Type 2 diabetics who have previously failed on standard Roberto Diaz-Rohena1, Alex Kartvelishvili1, Victor H. Gonzalez2. 1Valley Retina laser therapy. Decrease in belly fat generated cytokines may play a role following Institute,PA, MCALLEN, TX; 2Valley Retina Institute PA, McAllen, TX. weight loss. Purpose: To analyze the effect that the administration of intravitreal pegaptanib Commercial Relationships: Bernard J. Fowler, None sodium injections every 4 weeks, as compared to every 6 weeks, have on best- Support: None corrected visual acuity (BCVA) and on area and volume of diabetic macular edema (DME) as measured by optical coherence tomography (OCT) in patients with DME. Program Number: 352 Poster Board Number: D903 Methods: A total of 72 patients in 10 study sites across the United States were Presentation Time: 8:30 AM - 10:15 AM enrolled. A total of 64 patients completed the study. Only 1 eye from each patient Gas-Assisted Posterior Vitreous Detachment For The Treatment Of Diabetic was included in the study. All study eyes had foveal thickness of 250 microns or Macular Edema more on OCT, and BCVA between 70 and 20 letters on Early Treatment Diabetic Alessandro J. Dare1, Jose A. Cardillo2, Rogerio A. Costa3, Eduardo Moreira4, Retinopathy Study (ETDRS) chart. Eyes that had any confounding factors, that Francyne Tognin4. 1Ophthalmology, CBEO, Ribeirao Preto, Brazil; 2Retina could cause macular edema or decrease in vision or could interfere with treatment Department, Hospital de Olhos de Araraquara, Araraquara, Brazil; 3Division of results, were excluded. The study was conducted in compliance with the Macula: Imaging & Treatment, Centro Brasileiro de Ciencias Visuais, Belo Declaration of Helsinki, and all patients signed informed consent. Horizonte, Brazil; 4Ophthalmology, Hospital de Olhos de Araraquara, Ribeirao Results: There was a total of 49 patients in the 4-week arm, and 23 patients in the Preto, Brazil. 6-week arm. Mean baseline visual acuity (VA), central subfield thickness (CST), Purpose: To assess the functional and anatomic outcomes of a single intravitreous macular volume, and center point thickness (CPT) were comparable between the 2 perfluoropropone (C3F8) gas injection to treat patients with tractional DME, as study arms. Mean change in visual acuity by week 24 was +7.2 letters in 4-week assessed by optical coherence tomography (OCT). arm, and +0.2 letters in 6-week arm (P= 0.018). Mean change in CST on OCT at Methods: Five patients previously treated with focal grid photocoagulation, with week 24 was -9 microns in 6-week arm, and -71 microns in 4-week arm (P= 0.042). tractional diabetic macular edema received an intravitreous gas injection and were Mean change in macular volume on OCT at week 24 was -0.9 mm3 in 6-week arm, prospectively followed with optical coherence tomography. After informed consent and -0.42 mm3 in 4-week arm (P= 0.446). Mean change in CPT on OCT at week was obtained, the compromised eye was injected with 0.4 ml C3F8 gas using a 30- 24 was -2 microns in 6-week arm, and -47 microns in 4-week arm (P= 0.240). gauge needle via the pars plana. Patients maintained a head-prone posture for 14 Conclusions: The results demonstrate that the administration of pegaptanib sodium days. Changes in vitreous-macular relationship and central macular thickness were injections every 4 weeks as opposed to every 6 weeks resulted in higher gain of assessed using optical coherence tomography. Patients were followed 1 week, 2 letters on ETDRS chart. CST also improved more in 4-week arm than in 6-week weeks, 1, 2, 3, and 6-months after treatment. ETDRS best correct visual acuity and arm, although macular volume and CPT failed to show statistically significant fluorescein angiography were assessed during follow up. difference between the 2 groups. Results: A complete posterior vitreous detachment was achieved within 4 weeks Commercial Relationships: Roberto Diaz-Rohena, None; Alex Kartvelishvili, after gas injection in 3 of the 5 patients. By 6 months of follow-up after induced None; Victor H. Gonzalez, Eyetech, Alimera Sciences, Genentech, Regeneron, separation of the hyaloid at the fovea, there was resolution of the macular edema Iconic, Thrombogenics, Ophthotec, Steba, Alcon, DRCR.net, Pfizer, Ista and restoration of the foveal depression. No complication was related to the Pharmaceuticals (F), Eyetech, Genetech, Ista Pharmaceuticals, Pfizer (C), Eyetech, procedure. Vitrectomy were performed in those patients whom completed vitreous Ista Pharmaceuticals, Pfizer (R) detachment were not obtained with gas injection. Support: Eyetech Conclusions: The pneumatically-assisted vitreofoveal separation is a relative Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) simple outpatient procedure with minimal surgical manipulation and low morbidity Yufei Tu, Catherine Fay, Suqin Guo, Edward Marcus, Neelakshi Bhagat. Institute that may have broad therapeutic use. of Ophthalmology & Visual Science, UMDNJ-New Jersey Medical School, Commercial Relationships: Alessandro J. Dare, None; Jose A. Cardillo, Newark, NJ. None; Rogerio A. Costa, None; Eduardo Moreira, None; Francyne Tognin, Purpose: To evaluate the safety of ranibizumab as a surgical adjunct during None cataract surgery in patients with proliferative diabetic retinopathy (PDR) with Support: None rubeosis, and to evaluate the efficacy and adverse effects of ranibizumab in treating PDR with rubeosis. Methods: Three intravitreal injections of 0.5 mg ranibizumab were administered Program Number: 353 Poster Board Number: D904 on day 0, month 1 and 2 with cataract surgery 6-16 days after 1st injection. Presentation Time: 8:30 AM - 10:15 AM Retreatments with ranibizumab injections and pan-retinal photocoagulation (PRP) Does Preoperative Intravitreal Bevacizumab Reduce The Incidence Or were given if recurrence or persistence of PDR was noted between months 3 to 11. Severity Of Postoperative Diabetic Vitreous Hemorrhage? Safety observation visits occurred at months 12, 18 and 24. Primary end points Rocky L. McAdams, Richard Winslow, Georges Bounajem. Ophthalmology, UT were incidence and severity of adverse events (AE) that were related to both Southwestern, Dallas, TX. cataract surgery and treatment of PDR with rubeosis through month 12. Secondary Purpose: To examine the impact of preoperative intravitreal bevacizumab end points and results are summarized in Table 1. injections prior to vitrectomy on the rate of postoperative vitreous hemorrhage in Results: Of 6 patients screened, 4 (mean age 61.3) were enrolled. No AEs were diabetics with non-clearing vitreous hemorrhage or tractional retinal detachments. noted with either cataract surgery or treatment of PDR. Neovascularization of iris Methods: A retrospective chart review was conducted using ICD-9 and CPT codes (NVI) promptly regressed by 4 days after 1st ranibizumab injection, prior to to identify 121 eyes with proliferative diabetic retinopathy being treated with pars cataract surgery in 3 of 4 patients (one had significantly regressed NVI by post- plana vitrectomy at Parkland Hospital between 2006 and 2010. Chart review was injection day 3 visit); NVI was not noted in any patient at 2 weeks after 1st done to pull pertinent data from all preoperative and up to 3 months postoperative ranibizumab injection. Recurrence of rubeosis or NVA after 3 monthly injections visits including the use of bevacizumab. was not observed in any patient. At month 12, PDR was not present assessed Results: At 1 week and at 3 months post op the rate of any significant hemorrhage clinically nor by fluorescein angiogram. Only 1 patient developed was 12.5 % and 26.9% in the bevacizumab group compared to 26.2% and 45.8% neovascularization of disc and neovascularization elsewhere and required respectively in the observation group. These results trend to have decreased rate of retreatments at months 5 and 9. hemorrhage in the injection group. The timing of the injection did not show a Conclusions: Multiple intravitreal injections of ranibizumab may be a safe, statistical difference in the measured outcome. effective treatment adjunct for PDR with diabetes related rubeosis in absence of Conclusions: The results suggest a trend toward decreased rates of postoperative retinal traction membranes. It might serve as a more timely treatment alternative for vitreous hemorrhage with a preoperative bevacizumab injection in patients with patients with dense cataracts, which prevents them from undergoing immediate non clearing vitreous hemorrhage and tractional retinal detachments from PRP, the standard therapy of PDR. Ranibizumab treatment may have further proliferative diabetic retinopathy. Further research is still needed to establish the benefits of reducing bleeding complications during anterior segment surgery in a value of implementing preoperative therapy in this important postoperative rubeotic eye. complication. Commercial Relationships: Rocky L. McAdams, None; Richard Winslow, None; Georges Bounajem, None Support: None Program Number: 354 Poster Board Number: D905 Presentation Time: 8:30 AM - 10:15 AM Intravitreal Pegaptanib Sodium Prior to Pars Plana Vitrectomy in Proliferative Diabetic Retinopathy: An Update Karl E. Waite1A, Michael D. Bennett1. AOphthalmology, 1Retina Institute of Hawaii, Honolulu, HI. Purpose: To explore the efficacy and safety of pegaptanib sodium used as adjuvant therapy prior to pars plana vitrectomy in eyes with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD). Methods: Consecutive patients with PDR who required pars plana vitrectomy due to vitreoretinal traction to the macula received intravitreal pegaptanib 0.3 mg injection 5 to 14 days prior to the surgical procedure. Eyes with vitreous hemorrhage precluding preoperative fundus assessment and those treated during the previous month with anti-VEGF agents were excluded from this analysis. Best corrected visual acuity (BCVA) was evaluated at baseline and after vitrectomy. The effects of pegaptanib on regression of retinal neovascularization and progression of macular traction were assessed by comparing color fundus photographs and optical Commercial Relationships: Yufei Tu, None; Catherine Fay, None; Suqin Guo, coherence tomography (OCT) exams obtained pre- and post-injection. The ability None; Edward Marcus, None; Neelakshi Bhagat, None to dissect vitreoretinal tractional membranes from the underlying retina was Support: Genentech Inc. assessed by the surgeon. Clinical Trial: http://www.clinicaltrials.gov, NCT01069341 Results: Five patients have been treated with preoperative pegaptanib. Regression of neovascularization has been observed in follow-up images. There was no Program Number: 356 Poster Board Number: D907 evidence of increased traction, postoperative hemorrhage, or endophthalmitis in Presentation Time: 8:30 AM - 10:15 AM any patient. Adverse events were consistent with the safety profile of pegaptanib. Panretinal Photocoagulation Versus Intravitreal Injection Retreatment Pain Conclusions: This supports the potential use of intravitreal pegaptanib sodium as in High-Risk Proliferative Diabetic Retinopathy an adjuvant therapy prior to pars plana vitrectomy in diabetic retinopathy with Felipe P. Almeida1A, Célia R. Lucena1A, José A. Ramos1A, Andre Messias1A, José A. tractional retinal detachment. Larger scale, randomized clinical studies are still Silva1B, Ingrid U. Scott2, Rodrigo Jorge1C. AOphthalmology, BPsychology, Faculty required to appropriately evaluate the benefit of selective VEGF inhibition in this of Philosophy, Sciences and Literature, COphthalmology, Ribeirao Preto Med Sch, condition. 1University of Sao Paulo, Ribeirao Preto, Brazil; 2Ophthalmology & Public Health Commercial Relationships: Karl E. Waite, None; Michael D. Bennett, Eyetech Sciences, Penn State College of Medicine, Hershey, PA. (C), Genentech (C), Heidelberg (C), Optimedica (C), Optos (C), Optovue (C) Purpose: Compare pain score between panretinal photocoagulation (PRP) or Support: None intravitreal injection of ranibizumab (IVR) in patients with proliferative diabetic Clinical Trial: http://www.clinicaltrials.gov, RIH1005 retinopahty (PDR) already treated with PRP. Methods: PRP patients (n = 16) received full scatter PRP in two sessions (Weeks 0 Program Number: 355 Poster Board Number: D906 and 2) while the PRP plus group (n = 17) received the same LASER treatment and Presentation Time: 8:30 AM - 10:15 AM an additional IVR at week 0 (immediately after the 1st PRP session). After week Multiple Intravitreal Injection of Ranibizumab in Patients with Dense 16, the patients of both groups underwent a fluorescein angiography (FA). If Cataract and Proliferative Diabetic Retinopathy with Rubeosis: a 12- month leakage were shown, PRP group patients would receive an additional PRP session Interventional Study (500 additional spots per quadrant of active new vessels) and PRP plus patients received an additional IVR. Fifteen minutes after the end of, a masked examiner used a 100-degree Visual Analog Scale (VAS) for pain score estimation. Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) Results: Sixteen and 17 patients from the PRP and PRP plus groups respectively ischaemia (r=0.59 p=0.0003) and maculopapillar ischaemia (r=0.52 p=0.002). The completed the 16-week visit, and 14 patients from PRP and 17 from PRP plus were ratio of inner:outer retinal volume in ETDRS areas 1-9 was negatively correlated to evaluated for pain scores. At week 16, all patients from both groups showed FAZ size (r=-0.29, p= 0.04). A negative correlation was also observed with inner leakage confirmed by FA, and were retreated according to study protocol. Mean retinal (r=-0.31 p=0.03) but not outer retinal intensity (r=0.09 p=0.51). IVR pain (±SEM) was 4.7 ± 2.1, significantly lower (p<0.0001) than mean PRP Conclusions: The extent and location of diabetic macular ischaemia is associated pain (60.8 ± 7.8). Twelve out of 17 patients from the PRP plus group referred no with a reduction of visual acuity and disruption of Inner retinal architecture. The pain (score zero) with the intravitreal injection treatment while the minimal score prognostic significance of macular ischaemia is not well understood. Its found in one patient of PRP group was 10.5 while all others scored above 30. characterization is an important first step to determine the time point in which Conclusions: PRP plus ranibizumab is superior to PRP alone for high-risk PDR patients may be amenable to future regenerative therapies. treatment of BCVA and new vessels regression. In addition, the patient comfort is higher when treatment is performed with an additional intravitreal injection. Further larger studies are necessary to confirm the findings here reported. Commercial Relationships: Felipe P. Almeida, None; Célia R. Lucena, None; José A. Ramos, None; Andre Messias, None; José A. Silva, None; Ingrid U. Scott, None; Rodrigo Jorge, None Support: None Clinical Trial: http://www.clinicaltrials.gov, NCT01102946 Program Number: 357 Poster Board Number: D908 Presentation Time: 8:30 AM - 10:15 AM Structural and Functional Macular Evaluation in Proliferative Diabetic Retinopathy patients treated using Panretinal Photocoagulation Combined with Intravitreal Bevacizumab Injections Rony C. Preti, Lisa M. Ramirez, Andre C. Barros, Augusto A. Motta, Celso Morita, Otacilio O. Maia Junior, Daniel A. Ferraz, Walter Y. Takahashi. ophthalmology, MD, University of Sao Paulo, Sao Paulo, Brazil. Purpose: To investigate the effects of panretinal photocoagulation (PRP) combined with intravitreal injections of Avastin® (Bevacizumab) as an adjuvant to proliferative diabetic retinopathy (PDR) Methods: Prospective randomized masked study conducted in patients with high- risk PDR, which were divided into two groups. One eye was treated with only PRP Commercial Relationships: Dawn A. Sim, None; Pearse A. Keane, None; Elise (PRP only group) and the fellow eye of same patient was treated with both PRP and Platteau, None; Javier Zarranz-Ventura, None; Marcus Fruttiger, intravitreal bevacizumab injections (Adjuvant group). Best corrected visual acuity None; Praveen J. Patel, None; Catherine A. Egan, None; Adnan Tufail, None (BCVA), central macular thickness (CMT) and macular volume (MV) were Support: Fight For Sight, NIHR - National Institute for Health Research immediately recorded and also at the 1, 3 and 6 month’s follow-up visits. Results: Of 30 patients with high-risk PDR, sixteen were male and fourteen were Program Number: 359 Poster Board Number: D910 female. The average age and duration of the diabetes were 55(±7.87) and Presentation Time: 8:30 AM - 10:15 AM 17.77(±9.12) years, respectively. There were no statistically significant BCVA Effects of Macular Ischemia on Post-operative Visual Acuity, Foveal changes after treatment in either group throughout the follow-up period. CMT Thickness and Outer Retinal Layer Integrity after Pars Plana Vitrectomy demonstrated improvement just in the first month follow-up in the adjuvant group (PPV) for Proliferative Diabetic Retinopathy (PDR) (P<0.035). MV improved in the first (P<0.07) and third month follow-ups in the Hemang K. Pandya, Wendewessen Amde, Tamer H. Mahmoud. Ophthalmology, adjuvant group (P<0.02). Kresge Eye Institute, Detroit, MI. Conclusions: Intravitreal bevacizumab injection with PRP resulted in reduced Purpose: Proliferative Diabetic Retinopathy (PDR) is the primary cause of CMT and MV one and three months after treatment. There was no difference in the irreversible blindness in Western World. Pars Plana Vitrectomy (PPV) is a surgical BCVA between the two groups during the six-months of follow-up. approach for managing complications from PDR, such as vitreous hemorrhage. Our Commercial Relationships: Rony C. Preti, None; Lisa M. Ramirez, study attempts to correlate foveal avascular zone (FAZ) area to visual acuity (VA), None; Andre C. Barros, None; Augusto A. Motta, None; Celso Morita, central foveal thickness (CFT) and outer retinal layer integrity after PPV for PDR- None; Otacilio O. Maia Junior, None; Daniel A. Ferraz, None; Walter Y. related complications. Takahashi, None Methods: Retrospective review of 27 eyes treated with PPV for complications of Support: Fundacao de Amparo a Pesquisa do Estado de Sao Paulo processo PDR by single surgeon. Measured outcomes were visual acuity, foveal avascular numero 2009/08895-1 zone, central foveal thickness, and outer retinal layer integrity. Clinical Trial: http://www.clinicaltrials.gov, NCT01389505 Results: VA improved after PPV (p<0.0001). There was a significant negative correlation between FAZ area & CFT (p= 0.02). Wider FAZ correlated Program Number: 358 Poster Board Number: D909 significantly with disrupted external limiting membrane (p = 0.027) but not with Presentation Time: 8:30 AM - 10:15 AM disrupted photoreceptor inner/outer segment (IS-OS). Neither FAZ area nor CFT The Diabetic Retinopathy Repair Project - Prevalence And Prognostic correlated with VA. Significance Of Ischaemia In Diabetic Macula Disease Conclusions: Wider FAZ correlated with thin CFT. IS-OS integrity was not Dawn A. Sim1A,2A, Pearse A. Keane1A, Elise Platteau1A, Javier Zarranz-Ventura1A, affected by macular ischemia. Post-PPV VA may improve despite wider FAZ and Marcus Fruttiger2, Praveen J. Patel1B, Catherine A. Egan1A, Adnan Tufail1C. thinner CFT. AMedical Retina, BResearch & Development, COphthalmology, 1Moorfields Eye Commercial Relationships: Hemang K. Pandya, None; Wendewessen Amde, Hospital, London, United Kingdom; ACell Biology, 2UCL Institute of None; Tamer H. Mahmoud, None Ophthalmology, London, United Kingdom. Support: None Purpose: To investigate the relationship between Fundus Fluorescein Angiography (FFA) and Optical Coherence Tomography (OCT) derived measurements of retinal Program Number: 360 Poster Board Number: D911 vascular morphology and visual acuity in Diabetic Macular Ischaemia (DMI). Presentation Time: 8:30 AM - 10:15 AM Methods: Data were retrospectively collected over a period of 6 months. FFAs Angiofibrotic Response To VEGF Inhibition In Membranes Extracted During were analysed by 3 independent graders using the Early Treatment Diabetic Diabetic Vitrectomy: Results Of A Randomized, Controlled, Translational Retinopathy Study (EDTRS) protocol for DMI. The Foveal Avascular Zone (FAZ), Study capillary non-perfusion areas, and OCT images were quantified using custom Elliott H. Sohn1, Christine Spee2, Shikun He3, Dean Eliott4, David R. Hinton5. software. 1Retina Service, University of Iowa Hospitals and Clinics, Iowa City, IA; Results: 1298 unique patient attendances were identified. 1534 eyes from 767 2Ophthalmology, Keck Sch of Med, Univ of So CA, Los Angeles, CA; Type 2 diabetic patients included in the analysis. 45.4% of eyes had no DMI, 3Ophthalmology-USC, Doheny Eye Institute, Los Angeles, CA; 4Retina Service, 16.5% questionable, 16.4% mild, 7.9% moderate, and 3.7% severe ischaemia. Massachusetts Eye and Ear Infirmary, Boston, MA; 5Pathology, Keck School of Mean FAZ area (mm2) ranged from 0.21 in no DMI to 0.63 in severe DMI. Visual Medicine USC, Los Angeles, CA. acuity (VA) was reduced in all grades of DMI compared to those with no DMI Purpose: Connective tissue growth factor (CTGF) is a fibrosis inducer that is (p<0.003). VA reduction was correlated FAZ size in the moderate (r=0.47 p=0.006) elevated in proliferative diabetic retinopathy. The goal of this study was to and severe DMI (r=0.30 p=0.02) subgroups, and in cases with concurrent temporal determine the expression of vascular endothelial growth factor (VEGF) and CTGF Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) in membranes causing diabetic traction detachment with regard to vascular retinopathy were retrospectively analysed. The later four years saw the endothelial cells, myofibroblasts, and cytokeratin. commencement of routine use of IVB (1.25mg 4-9 days prior to operating). All Methods: In a randomized, controlled, prospective trial (www.clinicaltrials.gov patients with follow-up of at least six weeks were included. Surgery was performed NCT01270542) of 20 eyes (n=10 controls, n=10 given preoperative bevacizumab by three different vitreoretinal surgeons at two hospitals in East Africa 3-7 days prior to diabetic traction detachment surgery), epiretinal membranes were (Kilimanjaro Christian Medical Centre, Tanzania and Kikuyu Eye Unit, Kenya). excised at the time of vitrectomy. The membranes were snap frozen and sectioned Results: Initial data was compiled for 140 patients (158 eyes). Of the included eyes at 9 µm. Sections were immunofluorescent stained with anti-CTGF or anti-VEGF 46 (43%) had received IVB the remaining 62 (57%) had not. The main indications antibody followed by antibody specific for endothelial cells (CD31), for surgery were vitreous haemorrhage (39%) and tractional retinal detachment myofibroblasts (smooth muscle actin [SMA]), or cytokeratin. Volocity software (54%). The majority of patients required delamination surgery (81%). The (version 5.4) allowed quantitative and co-localization analysis of antibody content distribution of the above surgical indications and requirements was even to within obtained through immunofluorescence confocal microscopy. Multiple sections for 4% between the two groups. Intraoperative complications were higher in the each membrane were averaged for each eye. patients who had not received IVB. Significant haemorrhage occurred in 8 (11%) Results: The bevacizumab group had a greater than 25% reduction in co- compared to 1 (1.8%) in those who had received IVB. Similarly iatrogenic breaks localization in the CD31-CTGF and cytokeratin-CTGF studies compared to were more common, 33 (44.6%) to 19 (35%). The number needed to treat to restore controls. There was no change in VEGF colocalization between the treated and sight to one blind person (both eyes < 20/200) was 5.1 for those who received IVB controls. See figure for complete results. and 7.7 for those who did not. Conclusions: Intravitreal bevacizumab 1.25 mg administered within one week of Conclusions: This is the first study to indicate that a relatively inexpensive surgery may decrease VEGF and CTGF expression in diabetic traction membranes. preoperative dose of bevacizumab can improve surgical outcomes in PRD surgery VEGF inhibition decreases co-expression of CTGF but not VEGF in vascular in East Africa. The improved outcomes are largely a result of Bevacizumab endothelial cell and cytokeratin stains. Attenuation of fibrovascular activity in antiangeogentic actions improving intraoperative visualization of the retina. This membranes might provide scientific rationale for performing surgery within 7 days audit shows that IVB should be considered a cost-effective intervention in the of preoperative adjunctive bevacizumab for diabetic traction detachment. treatment of PDR in the developing world. Commercial Relationships: Grant Guthire, None; Anthony Hall, None; Kazim Dhalla, None Support: None Program Number: 362 Poster Board Number: D913 Presentation Time: 8:30 AM - 10:15 AM A Comparison of Surgical Outcomes After Diabetic Tractional Retinal Detachment Repair Using Small Versus Large Gauge Vitrectomy John Au, Alex Yuan, Jonathan Sears, Rishi Singh, Peter Kaiser. Cole Eye Institute, Cleveland Clinic, Cleveland, OH. Purpose: To compare surgical outcomes between traditional 20-gauge versus small (23 and 25) gauge vitrectomy surgery for diabetic tractional retinal detachment (TRD) repair. Methods: We reviewed medical records of patients who underwent TRD repair by either large or small gauge vitrectomy between 11/2008 and 4/2011. To date, 27 consecutive patients who underwent large gauge and 28 consecutive patients who underwent small gauge vitrectomy with an ICD-9 code for TRD were included with 6 months of followup. Baseline characteristics such as age, prior glaucoma, prior laser treatment (PRP or focal), preoperative lens status and preoperative visual acuity (VA) were compared between each group. The primary outcome was change in VA and secondary outcomes included operative times, surgical complications, post operative lens status, postoperative complications including redetachments, and the choice of posterior segment tamponade (silicone oil VS gas). Numerical data was analyzed by student T-test. Categorical data was analyzed by Fisher Exact test. Results: Baseline characteristics between the two groups were well matched with no significant differences. The numbers of combination phacoemulsification/vitrectomy cases were similar between both groups: 15 small gauge cases and 14 large gauge cases were combined with cataract extraction (p=1.0). The average operative time was 90±8.4 minutes for small gauge surgery and 140.2±10.2 minutes for large gauge. This difference was statistically significant (p=0.0005). There was a trend favoring small gauge surgery for visual outcomes. The average net gain in vision was 37±9 letters for small gauge and 11±10 letters for large gauge (p=0.052). The baseline VA was comparable for both Commercial Relationships: Elliott H. Sohn, None; Christine Spee, groups. The median baseline VA was 20/400 for small gauge and 20/1100 for large None; Shikun He, None; Dean Eliott, Genentech (C); David R. Hinton, None gauge (p=0.44). Median postoperative VA was 20/70 for small gauge and 20/200 Support: Research to Prevent Blindness. NEI Grant EY03040 for large gauge (p=0.01). There were no differences in rates of surgical and Clinical Trial: http://www.clinicaltrials.gov, NCT01270542 postoperative complications. There were 2 small gauge and 6 large gauge cases requiring reoperation (p=0.25). There was a statistically significant difference Program Number: 361 Poster Board Number: D912 favoring the use of silicone oil in large gauge surgery (p=0.005). Oil was used in 9 Presentation Time: 8:30 AM - 10:15 AM of 27 large gauge cases and only 1 of 28 small gauge cases. Bevacizumab As An Adjunct To Vitrectomy In The Management Of Conclusions: Though small in size, this preliminary study suggests that small Proliferative Diabetic Retinopathy In East Africa gauge TRD repair is significantly faster while yielding similar or superior outcomes Grant Guthire1, Anthony Hall2,3, Kazim Dhalla2. 1Newcastle Medical School, compared with traditional 20-gauge surgery. Newcastle Upon Tyne, United Kingdom; 2Kilmanjaro Christian Medical Centre, Commercial Relationships: John Au, None; Alex Yuan, None; Jonathan Sears, Moshi, Tanzania, United Republic of; 3Kikuyu Eye Unit, Kikuyu, Kenya. None; Rishi Singh, Buckeye Ocular, LLC (P), Oraya Therapeutics (E); Peter Purpose: Diabetes mellitus is an important public health problem worldwide. In Kaiser, Alcon Laboratories (E), Ophthotech (E, P), Oraya Therapeutics, Inc. (E, P) sub-Saharan Africa, its current incidence is 12 million. Although proliferative Support: None diabetic retinopathy (PDR) can be treated with laser some patients will need a vitrectomy. Preoperative intravitreal use of the antiangiogenic bevacizumab (IVB) Program Number: 363 Poster Board Number: D914 has been shown to reduce intraoperative complications by improving retinal Presentation Time: 8:30 AM - 10:15 AM visualization. The following multi-centre retrospective audit is the first study to Rational For ILM Removal In Diabetic Retinopathy assess surgical outcomes and the cost-effectiveness of IVB in vitrectomy for PDR Constantin J. Pournaras1A, Marie-Luce Bochaton-Piallat1B, Nicole Gilodi2, in an East African context. Efstratios Mendrinos1A. AVitreo-retinal Unit, Ophthalmology, BDepartment of Methods: Eight years of case notes from patients undergoing vitrectomy for PDR Pathology and Immunology, 1Geneva University Hospitals, Geneva, Switzerland; Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) 2Department of Ophthalmology, Geneva University Hospitals, Geneva, Program Number: 365 Poster Board Number: D916 Switzerland. Presentation Time: 8:30 AM - 10:15 AM Purpose: Myofibroblasts play a major role in the production of retractile Anatomic And Functional Surgical Outcomes Of Epiretinal Membrane phenomena causing contraction or shrinkage of the epiretinal membranes (ERM) in Secondary To Diabetes proliferative vitreoretinopathy, diabetic retinopathy or idiopathic macular epiretinal Isabelle Fournier, Jr., Laurent BALLONZOLI, Sr., Maher SALEH, Sr., Tristan membranes. To evaluate the expression of myofibroblasts on epiretinal macular BOURCIER, Sr., Claude SPEEG-SCHATZ, Sr., David GAUCHER, Sr.. Department tissue, in eyes with diabetic retinopathy undergoing of ophtalmology, Nouvel Hospital Civil, Strasbourg, France. vitrectomy. Purpose: To evaluate clinical features and surgical results of epiretinal membrane Methods: Samples of ERMs and/or ILMs following macular surgery in eyes with (ERM) secondary to diabetes and to compare them with idiopathic ERM. diabetic maculopathy or other diabetic-related complications were collected in 13 Methods: Data from 100 eyes of 97 consecutive patients operated on for ERM eyes. Samples included ILMs only in 7 eyes, ERMs only in 2 eyes and ERM with were reviewed retrospectively. Two groups of patients were studied: diabetic (37 ILM in 4 eyes. Double immunofluorescence staining with antibodies recognizing a- eyes) and nondiabetic (63 eyes). They were compared for best corrected visual SMA and ED-A FN or vimentine in myofibroblasts, followed by confocal acuity (BCVA), central macular thickness (CMT), intraretinal cysts before and after microscopy analysis as well as electronic microscopy were performed in all surgery, and the status of posterior vitreous detachment (PVD) during surgery. samples. Results: Complete PVD was less frequent in diabetic ERM (40.6%) than in Results: a-SMA in association to either ED-A FN or vimentine were detected in all idiopathic ERM (63.2%) (p=0.034). Although both groups showed significant ERM samples with or without ILM. In addition, ED-A FN or vimentine was improvement in BCVA, the diabetic group had poorer visual recovery (0.42±0.31 expressed in close relation with a-SMA-positive myofibroblasts in 2 out of 7 ILM vs 0.23±0.23 logMAR), CMT decreased after surgery in both groups, but final samples. CMT remained thinner in the diabetic group (313.68 vs 341.12µm) (p=0.0181). Conclusions: Scanning electron microscopy indicated that myofibroblats cellular Conversely, postoperative cystic spaces were more frequent in diabetic eyes migration is always expressed in epiretinal macular membrane. Most (5/7) of the (37.037% vs 13.725%) (p=0.0234). Preoperative BCVA was significantly ILM samples were negative for myofibroblasts, whereas 2 stained positive. These correlated with the visual improvement in the diabetic group. results suggest that in some cases ILM may contain myofibroblasts with no Conclusions: Removal of ERM secondary to diabetes can be recommended, macroscopic evidence of ERM. If during surgery, the ILM is colored especially to patients without DR. As complete PVD is less frequent in diabetic inhomogeneously, this suggests the presence of cells and should be peeled. If the patients, surgeons should take care to fully remove the posterior hyaloid while ILM is colored homogeneously, peeling is not considered necessary. operating diabetic patients for ERM. Commercial Relationships: Constantin J. Pournaras, None; Marie-Luce Commercial Relationships: Isabelle Fournier, Jr., None; Laurent Ballonzoli, Bochaton-Piallat, None; Nicole Gilodi, None; Efstratios Mendrinos, None Sr., None; Maher Saleh, Sr., None; Tristan Bourcier, Sr., None; Claude Speeg- Support: None schatz, Sr., None; David Gaucher, Sr., None Support: None Program Number: 364 Poster Board Number: D915 Presentation Time: 8:30 AM - 10:15 AM Program Number: 366 Poster Board Number: D917 The Effect of Pan-Retinal Photocoagulation on Macular Inner Retinal Presentation Time: 8:30 AM - 10:15 AM Thickness in Proliferative Diabetic Retinopathy Exploratory Analysis of Diabetic Retinopathy Worsening (Progression) at 1 Joshua A. Morrison-Reyes, Sam Mansour, Lindsay Smithen. Ophthalmology, Year and 3 Years in a Randomized Clinical Trial Evaluating Ranibizumab George Washington University, Washington, DC. and Triamcinolone Purpose: Panretinal photocoagulation (PRP) for patients with proliferative diabetic David G. Miller, Diabetic Retinopathy Clinical Research Network. Retina retinopathy (PDR) improves visual outcomes and prevents vision loss. Studies Associates of Cleveland, Cleveland, OH. using Time-Domain Ocular Coherence Tomography (TD-OCT) have shown an Purpose: Evaluate effect of intravitreal ranibizumab or intravitreal triamcinolone increase in edema and overall macular thickness following the procedure, but the acetonide on worsening (progression) of diabetic retinopathy. TD-OCT lacks the resolution to accurately measure the individual layers of the Methods: Exploratory analysis was performed on subjects with diabetic macular retina. It has not yet been investigated using Spectral-Domain OCT (SD-OCT) edema randomly assigned to sham+prompt laser, intravitreal 0.5-mg whether certain layers of the retina may thin even while overall thickness may ranibizumab+prompt laser, intravitreal 0.5-mg ranibizumab+deferred (>24 weeks) increase. laser, or 4-mg intravitreal triamcinolone+prompt laser. Fundus photographs were The purpose of this study is to conduct a retrospective analysis on patients with obtained at baseline, 1 year, and 1 additional time between 1.5 and 3 years. PDR who have undergone PRP and had SD-OCT before and after the procedure to Progression of retinopathy was defined as worsening from non-proliferative determine the change in thickness of the retinal layers after treatment at 1, 3, and 6 diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) (NPDR month intervals. eyes only), or occurrence of panretinal photocoagulation, or occurrence of vitreous Methods: All 99 patients with PDR who underwent a total of 202 sessions of PRP hemorrhage, or worsening of diabetic retinopathy severity level by at least 2 levels over a 2 year period were identified using the electronic medical record. Of these, (NPDR eyes only). Cumulative probabilities were calculated using the life-table 27 eyes from 18 patients met the criteria for inclusion, including no prior PRP, method. P values for the comparison of the scans at the appropriate intervals using SD-OCT, and clarity of optical media to ranibizumab or triamcinolone groups with sham+prompt laser, adjusted for permit adequate quality scans. Baseline scans were obtained before PRP, then at 1, baseline retinopathy severity level and baseline visual acuity, were computed using 3, and 6 months following. All patients were scanned using the Optovue RTVue proportional hazards regression. Results through 1 year are provided. system and scans were analyzed to determine the total, inner or “ganglion cell Results: For eyes without PDR at baseline (N = 538), the cumulative probability complex,” and outer retinal thickness; each measurement was taken at the fovea, with worsening was 10% (sham+prompt laser), 4% (ranibizumab+prompt laser, P 1.5mm (parafoveal) and 3mm (perifoveal) from the center. Additionally, charts = 0.04), 4% (ranibizumab+deferred laser, P = 0.06), and 4% were reviewed to determine visual acuity, number of laser spots, years since (triamcinolone+prompt laser, P = 0.05). For eyes with PDR at baseline (N = 254), diagnosis of diabetes, age, sex, race, and presence of CSME or glaucoma. the cumulative probability with worsening was 20% (laser), 9% Results: Ages ranged from 35-75 years; the average age was 54. 89% were ranibizumab+prompt laser, P = 0.08), 2% (ranibizumab+deferred laser, P = 0.03), African-American and 11% were Hispanic. The baseline average total central and 5% (triamcinolone+prompt laser, P<0.01). foveal thickness was 282.96µ; this increased at the 1 month visit, then decreased at Conclusions: Intravitreal ranibizumab+prompt or deferred laser as well as the 3 month (258.58µ) and 6 months visits (234.88µ; p=0.061). Total parafoveal intravitreal triamcinolone+prompt laser appear to reduce the risk of worsening of thickness and perifoveal thickness did not change significantly. Average central diabetic retinopathy in eyes with NPDR or PDR. These results suggest that use of inner retinal thickness decreased from a baseline 85.8µ to 71.3µ at 6 months these drugs to prevent worsening of diabetic retinopathy is worth further (p=0.101). Average central outer retinal thickness decreased from 197.12 µ to investigation. Given the exploratory nature of these analyses, use of these 163.55 µ at 6 months (p=0.093). Patients with CSME showed a 12.7% decrease in treatments to reduce the probability of worsening of diabetic retinopathy is not total thickness at 6 months, while patients without showed a 20.67% decrease in warranted at this time. total thickness. Commercial Relationships: David G. Miller, Acuity, Allergan, Eli Lilly, Conclusions: The inner and outer retinal layers both decrease in thickness over the Genentech (R) 6 months following PRP in a pattern that trends towards but does not meet Support: NEI and the NIDDK, NIH, Department of Health and Human Services statistical significance. Interestingly, this trend is seen in patients both with and EY14231, EY14229, EY018817 without CSME, suggesting that the thinning effect is independent of resolution of Clinical Trial: http://www.clinicaltrials.gov, NCT00445003 concurrent macular edema. Commercial Relationships: Joshua A. Morrison-Reyes, None; Sam Mansour, Program Number: 367 Poster Board Number: D918 None; Lindsay Smithen, None Presentation Time: 8:30 AM - 10:15 AM Support: None Navilas Panretinal Photocoagulation in Diabetic Retinopathy: A Case Series Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) Ken Y. Lin, Stephanie Lu. Ophthalmology, University of California, Irvine, Irvine, 5 injections of pegaptanib sodium. Fluorescein angiogram was carried out at CA. baseline and at the final visit (week 30).The central retinal arteriolar (CRAE) and Purpose: An interventional case-series to evaluate the comfort and clinical efficacy venular equivalence (CRVE) on baseline angiogram and at week 30 were measured of the new panretinal Navilas photocoagulation in treating high-risk proliferative using a new software. In this software, the CRAE and CRVE can be calculated in diabetic retinopathy (PDR). patients with only the temporal part of the optic disc included in the colour fundus Methods: Thirty consecutive eyes of 30 patients with high-risk PDR were treated image and in fluorescein angiogram images. Student t-test was used. with panretinal photocoagulation (PRP) using the Navilas photocoagulation system Results: Twenty seven patients have been recruited between January 2011 and (532nm laser). Spot size, ablated area, uniformity of the laser spots, duration of November 2011. Sixteen patients have to be excluded from the study. 2 patients treatment and patient comfort were assessed during the procedure. Regression of had received less than 3 injections, 3 patients had an early termination, 11 patients neovascularization was evaluated at 3 months after the first laser procedure. had poor quality images in either eye on fluorescein angiogram examination. In Results: In newly diagnosed PDR, eyes received an average of 1,590 laser spots many cases we managed to analyse the data in 3 out of 4 images but these were (1,203-1,731) in 4 quadrants in one single session. The average power intensity excluded for this analysis. The mean CRAE unit were 5.07 (SD 1.22) and 5.04 (SD used was 258mW at 30ms pulse duration using 300 microns spot size. Laser uptake 0.93) before and after treatment while the mean CRVE unit were 6.83 (SD 1.02) was consistent across the quadrants. Average procedure time was 7 minutes when and 7.11 (SD 0.83) before and after treatment. There were no significant changes in using the pattern scan mode. Visibility of the retina was superior under infrared CRAE (p=0.83) whilst CRVE is increased significantly (p=0.025). There were no mode in eyes with vitreous hemorrhage. There were no complications during or significant changes in the untreated eye either on CRAE or CRVE. The mean after the laser treatment. After 1 to 2 treatments, regression of neovascularization CRAE unit in the untreated group were 4.86 (SD 0.68) and 5.07 (SD 1.70) before was observed in 100% of patients within 3 months after the initial treatment. and after treatment. The mean CRVE were 7.37 (SD 1.08) and 7.31 (SD 2.03) Conclusions: Panretinal photocoagulation using Navilas is safe, well tolerated and before and after treatment. There was no significant change in the CRAE (p=0.72) achieves a high rate of clinical efficacy measured by regression of PDR. Retina and CRVE (p=0.91) units in the untreated eyes. visibility was better under infrared mode than the conventional color view. Laser Conclusions: This novel software appears to be able to measure retinal vascular uptake was consistent across the retina and regression of neovascularization was changes reliably in an angiogram. We were able to demonstrate, pegaptanib, a observed in 100% of the treated cases. selective anti-VEGF agent, has retinal venular dilatation effect. Our findings are in Commercial Relationships: Ken Y. Lin, None; Stephanie Lu, None keeping with previous studies that showed retinal venular dilation after non- Support: None selective anti-VEGF therapies. Commercial Relationships: Rupal Morjaria, None; Magdalena SincZak, None; Christine Kiire, None; Peter Bankhead, None; G. McGeown, None; T. Program Number: 368 Poster Board Number: D919 Curtis, None; Victor Chong, None Presentation Time: 8:30 AM - 10:15 AM Support: University of Oxford, Pfizer Combined Treatment of Proliferative Diabetic Retinopathy (PDR) Clinical Trial: http://www.clinicaltrials.gov, NCT01175070 Evgeny Smirnov. Novosibirsk Affiliate, S N Fyodorov's Eye Microsurgery Complex, Novosibirsk, Russian Federation. Purpose: : To study the efficacy of the intravitreal injections of ranibizumab prior Program Number: 370 Poster Board Number: D921 to the vitrectomy in surgical treatment of PDR. Presentation Time: 8:30 AM - 10:15 AM Methods: Study included 80 patients with PDR and clinically significant diabetic Pan-retinal Photocoagulation In High-risk Non-proliferative Diabetic macular edema (DME) from type I or II diabetes mellitus, aged 54-68 years. Retinopathy Baseline central retinal thickness (CRT) measured on Fourier-domain optical Cristos Ifantides, Barrett Eubanks, Daniel Taylor, Marc Peden. Ophthalmology, coherent tomography (OCT) (RTVue, model RT-100, Optovue, Fremont, CA) was University of Florida, Gainesville, FL. 370-490µm. Visual acuity (VA) varied from 20/200 to 20/320. Subtotal 25-guage Purpose: The Early Treatment Diabetic Retinopathy Study has shown that PRP vitrectomy (Constellation, Alcon, USA) was performed in all patients. When reduces the risk of severe visual loss in all stages of non-proliferative diabetic required, surgery was concluded by silicon oil or air/gas or balanced salt solution retinopathy (NPDR). The absolute risk reduction in this group of all-comer NPDR (BSS) tamponade of the vitreous cavity. Patients were randomly assigned to one of and the risk of deferring treatment, however, is small. Therefore, PRP treatment is the two equal groups: group I received intravitreal injection of ranibizumab 0.5mg usually deferred until patients develop PDR. Our study’s aim was to examine 8-14 days prior the surgery, group II (control) was followed up without intravetreal whether PRP reduces the risk of adverse events in a subgroup of patients known as injections. Morphological and functional outcomes of the treatments in groups I high-risk NPDR, as defined by capillary dropout on fluorescein angiography (FA). and II were analyzed and compared to the baseline data at 6-month time point after Specifically, we investigated whether PRP treatment at this high-risk stage leads to the surgery. improved outcomes measured as the lack of progression to PDR and vitreous Results: At 6 months after the surgery, VA in the control group was 20/200-20/100 hemorrhage (VH). (p=0.21), and CRT decreased by 50±20µm (p=0.041), whereas in the ranibizumab Methods: A retrospective chart review was performed at the University of Florida group, VA improved to 20/50-20/30 (p <0.05), and CRT decreased by ophthalmology clinic. Included patients had a prior diagnosis of high risk NPDR (Mean±St.D.) 110±70µm (p <0.05). Postoperative vitreous hemorrhages (in the confirmed with an FA identifying capillary-dropout, had no observation of areas of new vessels) were observed in after BSS tamponade: in the control group neovascularization, had no prior history of having a PRP treatment, and went on to hemorrhages developed in 27 patients (67.5%). In four of them (10%), additional have PRP treatment at our clinic. The patient’s fundus was examined for the revisions of the vitreous cavity were performed to remove blood. In the rest 23 development of VH or PDR. Data was analyzed using the Kaplan-Meier estimator. patients, hemorrhages resolved without treatment in 2-3 months. In the Incidence of conversion to PDR or VH was also calculated. Change in visual acuity ranibizumab group, hemorrhages developed in 11 patients (27.5%) and resolved was measured using a paired t-test and LogMAR conversion of visual acuity on a without treatment in 10-21 days. Snellen chart. Conclusions: Intravitreal injections of ranibizumab performed prior to vitrectomy Results: A search of the University of Florida database for eyes treated for the first for PDR and DME, significantly improve the efficacy of the vitrectomy, provide time with PRP for high-risk NPDR resulted in a total of 38 eyes in 23 patients. regression of new vessels thus decreasing the incidence of postoperative Incidence of VH following PRP treatment was 10.4% at one year post-treatment. hemorrhagic complications, and improve visual and morphological outcomes. Kaplan-Meier estimator resulted in 94.12% of patients without VH at six months Commercial Relationships: Evgeny Smirnov, None and 90.35% at one year and two years. Incidence of conversion to PDR following Support: None PRP treatment was 38.9% at one year post-treatment. Kaplan-Meier estimator resulted in 82.35% of patients without PDR at six months, 67.65% at one year, and 30.07% at two years. Paired t-test used for visual acuity changes showed no Program Number: 369 Poster Board Number: D920 significant difference in visual acuity at six months post-PRP treatment (p=0.206). Presentation Time: 8:30 AM - 10:15 AM Conclusions: Despite treatment with PRP at the high-risk stage of NPDR, there Retinal Venular Calibre Dilatation After Intravitreal Pegaptanib For was a significant amount of individuals who developed PDR within the year. Ischaemic Diabetic Macula Edema Using A Novel Software Rupal Morjaria1, Magdalena SincZak1, Christine Kiire1, Peter Bankhead2, G However, our incidence of VH at one year is substantially less than prior reports McGeown2, T Curtis2, Victor Chong1. 1Ophthalmology, Oxford Hospitals NHS (8.28% vs. 37%, respectively). Earlier treatment at this threshold of disease is more Trust, OXFORD, United Kingdom; 2Centre for Vision and Vascular Sciences, effective in mitigating VH than the convention of treating once retinopathy has become proliferative. Furthermore, there was no significant adverse effect on Queen's University of Belfasr, United Kingdom. vision. Further investigation is warranted in this high-risk non-proliferative group Purpose: To evaluate the retinal vascular changes in patients treated with to determine whether PRP is beneficial in reducing adverse outcomes prior to intravitreal pegaptanib compared to the untreated fellow eye using a novel conversion to PDR. software. Commercial Relationships: Cristos Ifantides, None; Barrett Eubanks, Methods: Patients with ischaemic diabetic macula edema resistant to treatment None; Daniel Taylor, None; Marc Peden, None with laser and / or intravitreal steroids have been recruited since January 2011. Support: None Patients were seen every 6 weeks for assessment and treatment, receiving a total of Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) Program Number: 371 Poster Board Number: D922 uniform across the retina, and not limited to the edematous areas. In other words, Presentation Time: 8:30 AM - 10:15 AM regions which did and did not develop edema worsened at similar rates (0.67/0.50 Functional and Structural Cone Abnormalities in Adolescents with Type 1 IT Z-scores; 0.63/0.49 Amp Z-scores respectively). Diabetes Conclusions: The early fundoscopic appearance of mild DME does not seem to Wylie Tan1,2, Yaiza Garcia-Sanchez1, Laura Finkelberg1,2, Tom Wright1, Marsha result in significant changes in VA in this pilot group. CS was depressed before Kisilak3, Melanie Campbell3, Carol Westall1,2. 1Ophthalmology and Vision DME developed and was not altered by DME onset. The mfERG neural function is Sciences, The Hospital for Sick Children, Toronto, ON, Canada; 2Institute of locally abnormal in patients with DR before edema develops and continues to Medical Science, University of Toronto, Toronto, ON, Canada; 3Department of worsen diffusely across the entire central retina (not only locally), as diabetic Physics and Astronomy, School of Optometry and WIN, University of Waterloo, disease progresses. Waterloo, ON, Canada. Commercial Relationships: Wendy W. Harrison, None; Marcus A. Bearse, Jr., Purpose: To identify biomarkers for Diabetic Retinopathy (DR) by examining the None; Glen Y. Ozawa, None; Marilyn E. Schneck, None; Kavita P. Dhamdhere, structure and function of the cone photoreceptor system in adolescents with Type 1 None; Shirin Barez, None; Anthony J. Adams, None Diabetes (T1D), no DR or mild nonproliferative DR (NPDR). Aims: 1) To identify Support: EY 02271 the retinal quadrants with greatest and least dysfunction using the multifocal electroretinogram (mfERG). 2) To examine cone density in areas identified in Aim Program Number: 373 Poster Board Number: D924 1 and other areas at similar eccentricities using Adaptive Optics Scanning Laser Presentation Time: 8:30 AM - 10:15 AM Ophthalmoscopy (AOSLO). Electroretinogram Findings in Patients with Proliferative Diabetic Methods: Patients with T1D, no DR or mild NPDR, and aged-matched controls Retinopathy after Argon Laser Photocoagulation were assessed for localized retinal function using the mfERG. The amplitude and Sung E. Watanabe, Somaia Mitne, Luciana C. Noia, Adriana Berezovsky, Paula Y. implicit time (IT) of the first order responses were averaged over 4 quadrants, Sacai, Solange R. Salomao, Augusto Paranhos, Jr.. Ophthalmology, Federal divided along the vertical and horizontal axes. Responses were compared between University of Sao Paulo, Sao Paulo, Brazil. patients and controls to identify the quadrants with greatest and least dysfunction. Purpose: The Diabetic Retinopathy Study has shown that panretinal A subset of these patients and controls underwent AOSLO imaging with a PSI photocoagulation with argon laser reduce the risk of severe visual loss due to multimodal AO instrument at 5° superior and 5° nasal and temporal. Images of the proliferative diabetic retinopathy. Consequently some degree of functional retinal cone mosaic (2°x2°) were used to compare cone densities between and within impairment should be expected after panretinal laser photocoagulation. The groups. purpose of this study is to evaluate retinal function through full-field Results: Fifty-three patients (16±2 years old) and 47 controls (17±3 years old) electroretinogram (ERG) after panretinal argon photocoagulation in patients with underwent mfERG testing. Quadrant (Q) amplitudes and IT were compared proliferative diabetic retinopathy. between patients and control using Student’s t-tests (p=0.0125 for multiple testing). Methods: Nine patients (17 eyes, 7 males) aging from 39 to 63 (mean=55±7.6) QIT in patients was delayed in the superior temporal (Q1, p=0.002), inferior years with ischaemic diabetic retinopathy had retinal function evaluated by full- temporal (Q3, p=0.005), and inferior nasal (Q4, p=0.003), but not in the superior field ERG before and after 6 months panretinal laser photocoagulation treatment. nasal (Q2, p=0.028). There were no significant differences in Q amplitudes ERG was recorded according to the International Society for Clinical between patients and controls. Ten patients and 7 controls underwent AOSLO Electrophysiology of Vision standard protocol. Wilcoxon test was performed imaging. Eleven images (5 controls, 6 patients) of the superior temporal and 8 between ERG responses before and after photocoagulation and random effects images (3 controls, 5 patients) of the superior nasal cone mosaic were taken. models were performed to account for the dependence between eyes of the same Qualitative assessment identified that cone densities of patients were lower than patient. controls, with the greatest difference (significant at p=0.02) being a relative Results: Statistically significant reduction in amplitude was found for rod response reduction in the superior nasal location. (p= 0.0000), maximal response (p=0.0000), oscillatory potentials (p= 0.0000), cone Conclusions: Relative cone dysfunction was greatest in the superior temporal and response (p=0.0000), and 30-Hz flicker response (p=0.0000) after panretinal least in the superior nasal quadrant in patients with diabetes compared with photocoagulation when compared to baseline ERG. No statistically significant controls. Qualitative examination on the small number of patients and controls who difference was found for rod latency (p=0.860) and b/a wave ratio (p=0.709), but underwent structural assessments showed that patients had a reduction in cone significantly delayed implicit time for cone response (p=0.0000). Greater amplitude density at both the superior temporal and nasal quadrants, with a significant deficit reductions were detected for rod response, maximal response and cone response. in the nasal location. Conclusions: Full-field ERG provided a sensitive measure of retinal function Commercial Relationships: Wylie Tan, None; Yaiza Garcia-Sanchez, impairment in patients with diabetic retinopathy treated with panretinal argon None; Laura Finkelberg, None; Tom Wright, None; Marsha Kisilak, None; photocoagulation. Despite the reduction in all ERG responses, the b/a-wave ratio Melanie Campbell, . (P); Carol Westall, None remained unchanged. These findings suggest that, the outer retina seems to be more Support: CFI, NSERC, CIHR, CHRP, JDRF, VSRP, SickKids RESTRACOMP, vulnerable to laser treatment in patients with diabetic retinopathy. BBDC Commercial Relationships: Sung E. Watanabe, None; Somaia Mitne, None; Luciana C. Noia, None; Adriana Berezovsky, None; Paula Y. Sacai, Program Number: 372 Poster Board Number: D923 None; Solange R. Salomao, None; Augusto Paranhos, Jr., None Presentation Time: 8:30 AM - 10:15 AM Support: None Retinal Function In Type 2 Diabetes Patients Who Develop Macular Edema: A Longitudinal Pilot Study Program Number: 374 Poster Board Number: D925 Wendy W. Harrison1,2, Marcus A. Bearse, Jr.2, Glen Y. Ozawa2, Marilyn E. Presentation Time: 8:30 AM - 10:15 AM Schneck2, Kavita P. Dhamdhere2, Shirin Barez2, Anthony J. Adams2. 1Arizona Retinal Function In Patients With Isquemic Diabetic Retinopathy Using Full- College of Optometry, Midwestern University, Glendale, AZ; 2School of field Electroretinogram Optometry, University of California Berkeley, Berkeley, CA. Mariana A. Coelho, Sung E. Watanabe, Somaia Mitne, Luciana C. Noia, Adriana Purpose: We have shown that the mfERG, along with other health factors, is a Berezovsky, Augusto Paranhos, Jr.. Ophthalmology, Federal University of Sao sensitive predictor of diabetic edema (DE) in an at-risk patient group. However, it Paulo, Sao Paulo, Brazil. is unclear how these factors change as diabetic macular edema (DME) develops. In Purpose: Evaluate full-field electroretinogram findings in patients with isquemic this pilot study, we examine changes in retinal and visual function in a group of diabetic retinopathy and correlate with visual prognosis type 2 diabetes patients before and after DME development. Methods: A group of 30 patients with pre-proliferative and proliferative diabetic Methods: A small high-risk group of type 2 diabetes patients (one eye each, n=7; retinopathy without previous photocoagulation had retinal function evaluated by aged 55.2 ± 9.3 years) was followed every 6-12 months until DME developed. All full-field electroretinography according to the International Society for Clinical had high HbA1c (10.4 ± 2.4%) and long disease duration (14.5 ± 6.6 years). All Electrophysiology of Vision standard protocol. The responses analyzed were: had diabetic retinopathy (DR) and no DME at the first visit (v1); all eyes had DME scotopic rod response, scotopic maximal response, scotopic response for oscillatory onset at the second visit (v2). mfERG, (VERIS 5.2) , blood pressure (BP), fundus potentials, photopic single-flash response and photopic 30Hz flicker for cone photos, visual acuity (VA), contrast sensitivity (CS), and HbA1c were obtained on response. all patients at both visits. mfERG implicit times (IT) and amplitudes (Amp) were Results: 30 eyes of diabetic retinopathy group and 20 eyes of subjects without normalized to Z-scores based on 52 controls, and grouped into 35 zones. diabetes were randomly selected. Mean age of diabetic retinopathy group (± 1 SD) Differences between v1 and v2 were evaluated. was 53.56 ± 9.91 years. The mean time of the diagnosis of diabetes was 13.96 Results: VA, CS, and HbA1c remained unchanged from v1 to v2 (p =0.30; 0.33; years. Mean values amplitude for rod response was 184.23 ± 62.29 µV, 322.47 ± and 0.47 respectively). VA was good for all patients (95 ± 6 letters; 20/25) but CS, 93.76 µV for maximal response; 59.02 ± 38.04 µV for oscillatory potentials; 84.15 although unchanged, was reduced (1.46 ± 0.12 log CS) at both visits. BP improved ± 38.19 µV for single-flash cone response and 59.43 ± 23.55 µV for light adapted v1 to v2 (141/83 to 128/75; p<0.02). Three eyes had retinopathy that clinically 30 Hz flicker response. Mean values b-wave implicit time was 97.48 ± 11.02 ms worsened between visits. Overall, IT became more delayed from v1 to v2 (p <0.05) for rod response; 35.81 ± 6.02 ms for single-flash cone response and 36.18 ± 6.39 and Amp trended toward decreasing (p = 0.08). These mfERG changes were Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) ms for 30 Hz flicker response. No statistically difference was found between the Purpose: In patients with diabetic retinopathy, panretinal photocoagulation (PRP) groups for rod response, maximal response, cone response and amplitude of light is performed to treat retinal ischemia. PRP, however, causes a reduction of blood adapted 30 Hz flicker response by gender. Statistically significant difference (p- flow, which is an undesirable side effect. A pattern scan laser (PSL) uses a shorter value < 0,001) was found between the diabetic retinopathy group and the normal pulse duration of spots which reduces collateral damage and thus the adverse group in oscillatory potentials and also b-waves implicit times for rod response, effects of PRP. This study compares retinal blood flow and visual function in cone response and flicker response. Diabetic patients with more severe condition, severe diabetic retinopathy following PRP using either a PSL or a conventional as vitreous hemorrhage and tractional retinal detachment (5 patients) had lower laser (CVL). responses for oscillatory potentials (4 patients), maximal response (4 patients) and Methods: Ten patients with diabetic retinopathy in both eyes underwent PRP using cone response (5 patients) when comparing to normal group. a PSL (2 sessions/ ≈3000 spots) in one eye, and PRP using a CVL (3 sessions/ Conclusions: The oscillatory potentials derive from the inner plexiform layers ≈2000 spots) in the other eye. Retinal blood flow was assessed with mean blur rate involving bipolar cells, amacrine cells and ganglion cells which are also involved in (MBR) measured by laser speckle flowgraphy of the optic disc once a month for 6 the physiopathology of the diabetic retinopathy. These findings suggest that months. Central macular thickness (CMT) measured by optical coherence changes in the oscillatory potentials and b-waves implicit times in the diabetic tomography and best-corrected visual acuity (VA) using a logMAR chart was also retinopathy may be the first sign of injury of the retina in this disease. Furthermore, evaluated. an increased degree of loss in amplitude of oscillatory potentials may be a Results: MBR was decreased during PRP in both the eyes treated with a PSL distinctive feature of diabetic retinopathy with poor visual prognosis. (73.2±6.9%) and the eyes treated with a CVL (71.5±8.0%). There was no Commercial Relationships: Mariana A. Coelho, None; Sung E. Watanabe, significant difference between the two groups. After completion of PRP, the MBR None; Somaia Mitne, None; Luciana C. Noia, None; Adriana Berezovsky, in the eyes treated with a PSL improved and was 89.4±8.3% at 6 months. The MBR None; Augusto Paranhos, Jr., None in the eyes treated with a CVL was unchanged (70.3±9.6% at 6 months: p<0.01). Support: None Both CMT and VA in the eyes treated with a PSL were unchanged during the clinical course, while those parameters in the eyes treated with a CVL worsened over time. Program Number: 375 Poster Board Number: D926 Conclusions: Compared to a CVL, PRP with a PSL resulted in rapid recovery of Presentation Time: 8:30 AM - 10:15 AM blood retinal flow after the completion of PRP, and had less influence on macular Electroretinographic Findings in Intravitreal Ranibizumab Association to function in patients with severe diabetic retinopathy. Photocoagulation for High-Risk Proliferative Diabetic Retinopathy Joaquim R. Valle1, Andre Messias2A, José A. Ramos1, Felipe P. Almeida2A, Ingrid Commercial Relationships: Sho Watarai, None; Shinji Onodera, U. Scott3, Rogerio A. Costa4, Florian Gekeler5, Rodrigo Jorge2B, Katharina S. None; Kanako Yasuda, None; Masayuki Yasuda, None; Toru Nakazawa, Messias2A. 1Ophthalmology, Ribeirao Preto Med Sch-U Sao Paulo, Ribeirao Preto, None; Masahiko Shimura, None Brazil; AOphthalmology, BOphthalmology, Ribeirao Preto Med Sch, 2University of Support: None Sao Paulo, Ribeirao Preto, Brazil; 3Ophthalmology & Public Health Sciences, Penn State College of Medicine, Hershey, PA; 4Division of Macula: Imaging & Program Number: 377 Poster Board Number: D928 Treatment, Centro Brasileiro de Ciencias Visuais, Belo Horizonte, Brazil; 5Centre Presentation Time: 8:30 AM - 10:15 AM for Ophthalmology, Tuebingen Univ Eye Hosp, Tuebingen, Germany. Are Proliferative Diabetic Retinopathy and Diabetic Macular Edema two Purpose: To evaluate retinal function after panretinal photocoagulation (PRP) different disease processes? A Retrospective Cross-sectional Study compared to PRP plus intravitreal injection of ranibizumab (IVR) in patients with Amar J. Patel1, Kenny Downes1, Alex Davis1, Arup Das1A. ADivision of high-risk proliferative diabetic retinopathy (PDR) by means of electroretinography Ophthalmology, 1University of New Mexico School of Medicine, Albuquerque, (ERG). NM. Methods: In a prospective study, patients with high-risk PDR and no prior laser Purpose: To evaluate whether diabetic macular edema (DME) and proliferative treatment were randomly assigned to receive PRP (PRP group; n=9) or PRP plus diabetic retinopathy (PDR) could represent two distinct clinical-pathological IVR (PRPplus group; n=11).PRP was administered in two sessions (weeks 0 and entities, or occur concurrently along the same spectrum of disease. 2), and IVR was administered at the end of the first laser session in the PRPplus Methods: The study is a retrospective cross sectional review of patients presenting group. Standardized ophthalmic evaluations including (ETDRS) best-corrected with PDR associated vitreous hemorrhage that were treated with either pan-retinal visual acuity (BCVA), and fluorescein angiographyto measure area of fluorescein photocoagulation (PRP), or pars plana vitrectomy (PPV) with endolaser. The leakage (FLA), were performed at baseline and at weeks 16 (±2), 32 (±2) and 48 presence or absence of macular edema was reviewed within 3-6 months of patient (±2). ERG was measured according to ISCEV standard at baseline and at week 48 presentation with vitreous hemorrhage in order to allow for a clear assessment of (±2). the macular status post intervention. The stereoscopic biomicroscopic fundus Results: After 48 weeks, 2400 to 3000 laser spots were made in eyes from PRP examination was completed with the OCT exam (central retinal thickness > 250 group, while only 1400 to 1800 spots were necessary in PRPplus.There was a um) to grade diabetic macular edema. An analysis was done to examine the statistically significant (p<0.05) FLA reduction at all study visitsin both groups, relationship of DME with risk factors like HbA1C, lipid panel, and systolic blood with the reduction observed in the PRPplus group significantlylarger than that in pressure. the PRP group at week 48. ROD b-wave amplitude was significantly reduced to 46 Results: A total of 263 patients were identified with active PDR associated ± 5 %(P<0.05) of baseline in the PRP group; and to 64 ± 6 %(P<0.05) in PRPplus. vitreous hemorrhage over the last six years with 124 undergoing PRP in clinic and This reduction was significantly higher in PRP than in PRPplus (P=0.024; t-Test). 139 undergoing PPV with endolaser. Patients who had undergone recent PRP The same was observed for SF amplitude: PRP: 45 ± 4 % and PRPplus: 62 ± 5 %; within the last 6 months were excluded. Of the 124 patients who underwent PRP in also showing higher reduction in PRP than in PRPplus (P=0.0094). SF a-wave, OP, clinic, the incidence of concurrent macular edema was 28%. Of the 139 patients CONE and 30 Hz showed statistically significant within group reductions, but no who underwent PPV with endolaser, the incidence of concurrent macular edema differences in between group analyses. was 13%. The results show 53 of the patients (20%) had diabetic macular edema Conclusions: These results suggest that treating high risk PDR with PRP plus IVR and active PDR concurrently. The majority (80%) of patients with active PDR did is effective for proliferative retinopathy control, and allow the use of less extensive not have exudative changes like CSME, indicating that PDR may be a different PRP, which induces less retinal functional loss, in particular for rod-driven post- disease process. receptoral responses, than treatment with PRP alone. Conclusions: This data showed that the majority of diabetic patients with active Commercial Relationships: Joaquim R. Valle, None; Andre Messias, retinal neovascularization (PDR) had little or no exudative changes in the macula. None; José A. Ramos, None; Felipe P. Almeida, None; Ingrid U. Scott, In spite of the high VEGF levels expected in these patients, there was absence of None; Rogerio A. Costa, None; Florian Gekeler, None; Rodrigo Jorge, macular edema in the majority of patients. It is possible that patients with diabetes None; Katharina S. Messias, None go through phases of non-proliferative diabetic retinopathy, and then follow either Support: None of two clinical pathways: predominantly exudative process (DME), or Clinical Trial: http://www.clinicaltrials.gov, NCT00993525 predominatly proliferative process (PDR). These findings indicate that PDR and DME could be two different disease processes driven by different molecular mediators or genetic factors. Program Number: 376 Poster Board Number: D927 Commercial Relationships: Amar J. Patel, None; Kenny Downes, None; Alex Presentation Time: 8:30 AM - 10:15 AM Davis, None; Arup Das, None Comparison Of Blood Retinal Flow In Severe Diabetic Retinopathy Treated Support: NEI RO1 12604 With Panretinal Photocoagulation Performed With A Pattern Scan Laser Versus A Conventional Laser Sho Watarai1, Shinji Onodera1, Kanako Yasuda1, Masayuki Yasuda2, Toru Nakazawa2, Masahiko Shimura1. 1Department of Opthalmology, NTT East Japan Tohoku Hospital, Sendai, Japan; 2Ophthalmology, Tohoku Univ Grad School of Med, Aoba-ku, Japan. Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected]. ARVO 2012 Annual Meeting Abstracts by Scientific Section/Group – Retina+ (RE) 112 Diabetic Macular Edema-Clinical Research I Conclusions: A novel grading protocol for diabetic macular edema based on 2 Sunday, May 6, 2012, 8:30 AM - 10:15 AM imaging techniques was generated allowing for an exact description of the amount Hall B/C Poster Session of alteration secondary to diabetic vasculopathy. As the main focus was to indicate Program #/Board # Range: 378-419/D929-D970 a possible treatment decision, this grading protocol could be used in a clinical Organizing Section: Retina+ setting, as well as for further specifying inclusion criteria or evaluating a treatment response in a clinical trial. Commercial Relationships: Matthias Bolz, None; Jan Lammer, Program Number: 378 Poster Board Number: D929 None; Christoph Mitsch, None; Christoph D. Scholda, None; Ursula Schmidt- Presentation Time: 8:30 AM - 10:15 AM Erfurth, None Observational Study of Worsening To Center- Involved Macular Edema Support: None Following Cataract Surgery in a Cohort with Diabetic Retinopathy Timothy J. Murtha, Diabetic Retinopathy Clinical Research Network. Beetham Eye Inst, Joslin Diabetes Center, Natick, MA. Program Number: 380 Poster Board Number: D931 Purpose: To estimate the incidence of center-involved macular edema (ME) at 16 Presentation Time: 8:30 AM - 10:15 AM weeks following cataract surgery in eyes with diabetic retinopathy and no definite Evaluation Of Macular Ischemia In Diabetic Macular Edema center involved diabetic macular edema pre-operatively. Secondary analyses Alexandros Deligiannidis1, Jose Lorenzo Carrero2. 1CHUVI Vigo, vigo, Spain; included visual acuity (VA) and assessment of baseline risk factors. 2Povisa Hospital, Vigo, Spain. Methods: Multi-center, prospective, observational study of eyes with OCT central Purpose: To evaluate the relationship between the macular ischemia and the visual subfield (CSF) thickness<250 um time domain (TD) or <310 um SD who had acuity in patients with diabetic macular edema. diabetic retinopathy and underwent cataract surgery < 28 days after enrollment. Methods: Sixty-two eyes from 37 patients diagnosed of diabetic macular edema The primary outcome was worsening to central-involved ME at 16 weeks, defined and with transparent media were included in the study. A comprehensive as CSF thickness of >250 um TD or > 310 um SD with > 1-step increase in the ophthalmologic examination was carried out. All patients underwent a digital high logOCT thickness compared to baseline, or > 2-step increase in the logOCT CSF resolution fluorescein angiography with a non-flash blue laser (488nm) confocal thickness from baseline or receiving treatment (other than eye drops) for ME prior ophthalmoscope (SPECTRALIS HRA2+OCT). Consecutively, a Spectral-Domain to 16 weeks on the basis of the above criteria. Protocol refraction, best corrected E- OCT with active eye tracking was performed. The OCT data obtained included ETDRS VA, fundus exam, and OCT were performed at all study visits. foveal thickness, macular volume and the disruption of the foveal photoreceptor Results: Two hundred seventy six eyes were eligible for analysis (median age layer. The ischemia was quantified with a computer-assisted image analysis 65yrs, median VA letter score 70 [approximate Snellen equivalent 20/40], and 42% software. Data from one eye of each patient were assessed with Pearson and had a history of treatment for DME). At 16 weeks post-op, preliminary results Spearman correlation analysis. show 30 eyes (11%) worsened to central-involved ME (95% CI 7-15%). Twenty- Results: Visual acuity was correlated significantly only with the disruption of the three eyes (8%) received post-op ME treatment other than eye drops; of these, 7 did foveal photoreceptor layer (P = ,022, r= - 0,397). The macular ischemia was not worsen to central-involved ME. At 16 weeks, 216 eyes (78%) achieved 20/40 strongly correlated with the disruption of the foveal photoreceptor layer (P = ,013, r or better VA. Of the 30 eyes that developed central-involved ME, 14 eyes (47%) = 0,428), but not with the macular volume, nor with the foveal thickness. achieved 20/40 or better VA. Among baseline factors evaluated, history of DME Conclusions: The macular ischemia was positively correlated with the disruption treatment (P<0.001), showed possible association with the primary outcome. of the foveal photoreceptor layer, independently of the macular volume or the Conclusions: Sixteen weeks after cataract surgery for eyes with diabetic foveal thickness. retinopathy but no definite center-involved edema, 7% to 15% will worsen to Commercial Relationships: Alexandros Deligiannidis, None; Jose Lorenzo central-involved edema. To our knowledge, it is unknown at this time how many Carrero, None similarly followed eyes without diabetes or diabetic retinopathy will worsen to Support: None center-involved edema. Going forward, research may clarify which individuals with diabetes are at highest risk for central-involved ME and whether treatments Program Number: 381 Poster Board Number: D932 might mitigate vision loss associated with development of central-involved ME Presentation Time: 8:30 AM - 10:15 AM after cataract surgery. Perifoveal Vascular Leakage In Patients With Diabetic Retinopathy Observed Commercial Relationships: Timothy J. Murtha, None With Spectral Domain Optical Coherence Tomography Support: NEI, NIDDK, NIH, Department of Health and Human Services Christoph Mitsch1, Matthias Bolz1, Jan Lammer2, Christoph Scholda1, Ursula EY14231, EY14229, EY018817 Schmidt-Erfurth1, Diabetic Retinopathy Research Group (DRRG) Vienna. 1Dpt. of Ophthalmology and Optometrics, Medical University of Vienna, Vienna, Austria; Program Number: 379 Poster Board Number: D930 2Dpt. of Ophthalmology and Optometrics, Medical University Vienna, Vienna, Presentation Time: 8:30 AM - 10:15 AM Austria. Evaluating A New Clinical Grading Protocol For Diabetic Macular Edema Purpose: Fluorescence Angiography (FA) remains the method of choice for the Matthias Bolz, Jan Lammer, Christoph Mitsch, Christoph D. Scholda, Ursula diagnosis and follow-up of a broad spectrum of retinal vascular abnormalities Schmidt-Erfurth, Diabetic Retinopathy Research Group Vienna. Department of secondary to diabetes mellitus. Recently, our group showed distinct leakage Ophthalmology, Medical University of Vienna, Vienna, Austria. patterns observable in patients with diabetic macular edema as seen in spectral Purpose: Apart from laser treatment, several new therapeutic agents have been domain optical coherence tomography (SD-OCT). We now want to describe developed for the treatment of diabetic macular edema (DME) in the recent years. alterations to the retinal architecture associated with perifoveal vascular leakage. However, it is not clear how the information originating from clinical trials can be Methods: 20 consecutive patients with diabetic retinopathy secondary to diabetes used for a treatment decision in an individual case of diabetic macular edema in mellitus type 2 were examined using the FA+OCT mode of the (Heidelberg daily clinical routine and if there are differences in the treatment response Engineering Spectralis HRA+OCT) during one same-day examination. FA images according to specific morphologic alteration. For this reason, a new grading system were then analyzed for diffuse, hyperfluorescent areas surrounding retinal vessels for DME was defined. and microaneurysms and the corresponding areas on the SD-OCT scans were Methods: 110 eyes showing DME were examined using 2 different spectral observed using the Heidelberg Engineering Eye Explorer Software. domain optical coherence tomography (SD OCT) devices (Cirrus©, Carl Zeiss Results: In all cases, structural alterations could be detected in the SD-OCT scans Meditec, and Spectralis OCT©, Heidelberg Engineering) and by performing a corresponding to locations of diffuse hyper-fluorescence in FA representing fluorescence angiography (FA) of the central and peripheral retina (Spectralis vascular leakage. SD-OCT images showed different stages of patho-morphological HRA, Heidelberg Engineering). Results were evaluated for characteristic imaging changes including mild signal dispersals of the SD-OCT signal or very small cystic findings that influence the treatment decision in a clinical setting, and based on spaces confined to the retinal inner nuclear layer (INL), cystic spaces and diffuse these findings a grading protocol was generated. In the next step, all OCT and FA SD-OCT signal dispersal in the outer nuclear layer (ONL) and cystic spaces images were evaluated by 3 blinded readers in order to evaluate the repeatability of throughout all retinal layers. Interestingly, all locations with significant retinal the generated grading system. thickening showed alterations in the outer nuclear layer, whereas significantly less Results: Giving respect to possible treatment decisions, the evaluation of the OCT retinal thickening was measured at locations with changes confined to the inner and FA images revealed 4 types of diabetic macular edema: Edema secondary to retinal layers. vitreoretinal traction, focal or generalized edema in OCT secondary to focal Conclusions: Perifoveal vascular leakage causes morphological alterations leakage in FA, generalized edema in OCT secondary to generalized leakage in FA, observable in spectral domain optical coherence tomography. The detected changes generalized or focal edema in combination with central or peripheral ischemia. ranged from mild signal dispersal and cystic spaces confined to the INL to signal Each of these edema types was further specified by characteristic morphologic dispersal and cystic spaces in the INL and ONL, the latter case being more details. The generated grading protocol allowed for precise description of the commonly associated with local edema in the affected retinal area. individual amount of retinal alteration showing a significant inter-observer Commercial Relationships: Christoph Mitsch, None; Matthias Bolz, None; Jan reproducibility between the 3 blinded readers. Lammer, None; Christoph Scholda, None; Ursula Schmidt-Erfurth, None Copyright 2012 by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any abstract, contact the ARVO Office at [email protected].
Description: