OSLI Retina

April 2020

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210 Ophthalmic Surgery, Lasers & Imaging Retina | Healio.com/OSLIRetina ■ C L I N I C A L S C I E N C E ■ Long-Term Vision Outcomes in Patients With DME and a Limited Early Visual Response to Ranibizumab in RIDE and RISE Rishi P. Singh, MD; Dante J. Pieramici, MD; Pin-wen Wang, PhD; Shamika Gune, MD BACKGROUND AND OBJECTIVE: To compare early and long-term visual responses to ranibizumab in patients with diabetic macular edema. PATIENTS AND METHODS: Retrospective analysis of RIDE (NCT00473382) and RISE (NCT00473330). Vi- sion outcomes over 36 months were compared be- tween limited early gainers (gained ≤ 5 Early Treat- ment Diabetic Retinopathy Study [ETDRS] letters), early 1-line gainers (gained 6 to 9 ETDRS letters), and early 2-or-more-line gainers (gained ≥ 10 ETDRS letters) at Month 3. RESULTS: Among 235 ranibizumab-treated patients, 42.6%, 20.0%, and 37.4% were limited early gain- ers, early 1-line gainers, and early 2-or-more-line gainers, respectively. At Month 36, 71.3% of lim- ited early gainers achieved 6 to 9 and 10 or more ETDRS letter gains. Mean ETDRS letter scores at Month 36 were comparable between limited early gainers (67.8), early 1-line gainers (73.4), and early 2-or-more-line gainers (71.6). CONCLUSION: Clinically meaningful vision out- comes were achieved with long-term ranibizumab treatment, irrespective of early visual acuity re- sponse. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:210-218.] INTRODUCTION Anti-vascular endothelial growth factor (VEGF) therapy is the standard of care for patients with diabetic macular edema (DME), along with medical and lifestyle interventions to improve blood glucose control and other metabolic derangements. 1 Clinical trial data show that intravitreal injections of ranibi- zumab (Lucentis; Genentech, South San Francisco, CA), 2,3 aflibercept (Eylea; Regeneron, Tarrytown, NY), 4,5 or bevacizumab (Avastin; Genentech, South San Francisco, CA) 6 are superior to laser in terms of visual acuity (VA) and optical coherence tomogra- phy outcomes for up to 2 years. Improvements ob- served with anti-VEGF therapy are generally rapid, with clinically meaningful VA gains versus laser often achieved within 3 months. 2,5 In the phase 3 RIDE and RISE trials of adults with vision loss due to DME, statistically significant VA and anatomical improvements were observed as early as 7 days af- ter the first ranibizumab injection. 7 At present, clinical decisions are often based on anatomical responses to treatment, and retina spe- cialists frequently consider alternative anti-VEGF therapies after 3 to 6 months of limited response. 8-10 However, treatment decisions based on short-term and/or anatomical data are not supported by evi- dence describing long-term functional outcomes. 8-10 Previously, a post hoc subgroup analysis of RIDE/ RISE revealed that patients who continued monthly ranibizumab treatment despite a limited early ana- tomical response (≤ 10% reduction in central foveal From the Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio (RPS); California Retina Consultants, Santa Barbara, California (DJP); and Genentech, Inc., South San Francisco, California (PW, SG). Originally submitted October 15, 2019. Revision received December 12, 2019. Accepted for publication January 16, 2020. Presented in part at the 49th Annual Scientific Meeting of the Retina Society, September 14-17, 2016, San Diego, CA; and the 20th Annual Club VIT Annual Meeting, June 28-July 1, 2017, Mykonos, Greece. Supported by Genentech, Inc., a member of the Roche Group. The sponsor participated in study design; collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication. Third-party writing assistance, provided by Karina D. Hamilton-Peel, PhD, CMPP, and Betsy C. Taylor, PhD, CMPP, of Envision Pharma Group, was funded by Genentech, Inc. Dr. Singh is a consultant for Alcon, Genentech, Optos, Regeneron, and Zeiss and receives research payment from Alcon, Apellis, Genentech, Regeneron, and Roche. Dr. Pieramici is a consultant for Alimera, Allergan, Genentech, Santen, and ThromboGenics. Dr. Wang was an employee of Genentech during the course of this study (current employee of Philips Healthcare, Seattle, WA). Dr. Gune is an employee of Genentech. Dr. Singh did not participate in the editorial review of this manuscript. Address correspondence to Rishi P. Singh, MD, Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Avenue, i-32, Cleve- land, OH 44195; email: drrishisingh@gmail.com. doi: 10.3928/23258160-20200326-02

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