OSLI Retina

September 2018

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698 Ophthalmic Surgery, Lasers & Imaging Retina | Healio.com/OSLIRetina ■ E X P E R I M E N T A L S C I E N C E ■ Visual Acuity Outcomes in Diabetic Macular Edema With Fluocinolone Acetonide 0.2 µg/Day Versus Ranibizumab Plus Deferred Laser (DRCR Protocol I) Michael A. Singer, MD; Dan M. Miller, MD, PhD; Jeffrey G. Gross, MD; Craig M. Greven, MD; Barry Kapik, MS; Clare Bailey, MD, FRCOphth; Faruque Ghanchi, MBBS, FRCOphth; Baruch D. Kuppermann, MD, PhD BACKGROUND AND OBJECTIVE: Visual outcomes of the FAME study (0.2 µg/day fluocinolone aceton- ide [FAc]) and Protocol I (0.5 mg ranibizumab plus deferred laser) were compared using the area under the curve (AUC) analysis method. PATIENTS AND METHODS: Best-corrected visual acu- ity (BCVA) data collected during a period of 3 years of follow-up for patients enrolled in FAME or Pro- tocol I were used to calculate AUC of the change in BCVA over a time curve. RESULTS: In the overall population, there was a greater treatment effect for ranibizumab plus de- ferred laser compared with FAc. However, for sub- groups of pseudophakic eyes, eyes with chronic diabetic macular edema (DME), and pseudophakic eyes with chronic DME, ranibizumab plus deferred laser and FAc were not found to be significantly different. The ranibizumab group received a me- dian of 14 injections during a 36-month period compared with a mean of 1.3 injections in the FAc group. CONCLUSION: In pseudophakic and chronic DME subgroups, FAc was comparable to ranibizumab plus deferred laser with fewer injections. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:698-706.] INTRODUCTION Diabetic macular edema (DME) is a severe, vision- threatening stage of diabetic retinopathy (DR) — a leading cause of vision loss worldwide. 1 Although intravitreal anti-vascular endothelial growth factor (VEGF)-A injections have been demonstrated as effec- tive in managing DME, reducing progression of DR, and treating neovascularization, 2,3 a broad spectrum of inflammatory events drives the pathogenesis and progression of DR 4 and the multifactorial nature of From University of Texas Health Science Center, San Antonio (MAS); Cincin- nati Eye Institute, Cincinnati (DMM); Carolina Retina Center, Columbia, SC (JGG); Wake Forest Baptist Medical Center, Winston Salem, NC (CMG); Alimera Sciences, Alpharetta, GA (BK); University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom (CB); Bradford Teaching Hospi- tals NHS Foundation Trust, Bradford, United Kingdom (FG); and UC Irvine Health Gavin Herbert Eye Institute, Irvine, CA (BDK). Originally submitted January 17, 2018. Revision received June 21, 2018. Accepted for publication August 3, 2018. This study was presented at the American Academy of Ophthalmology Annual Meeting, New Orleans, November 11-14, 2017. Financial support for this study was provided by Alimera Sciences (Alpharet- ta, GA). The sponsor participated in data collection, data management, data analysis, interpretation of the data, preparation of the manuscript, and review of the manuscript. Employees of Alimera Sciences participated in conducting the study, data acquisition analysis, and reporting. Dr. Singer has received financial support from Aerpio, Allergan, Ampio, Genentech, and Regeneron. Dr. Miller has received financial support from Alcon, Genentech, and Regeneron; has been a consultant for Alimera and Bausch + Lomb; and has a personal financial interest in Vortex. Dr. Gross has received financial support from Acucela, Ohr, and Regeneron. Dr. Greven is involved in clinical trials with Genentech (Roche) and Allergan. Mr. Kapik is an employee of Alimera Sciences. Dr. Bailey is a consultant for Allergan, Alcon, Bayer, Alimera Sciences, Roche and Novartis. Dr. Ghanchi has been a consultant for Alimera, Allergan, Bayer, and Novartis and has received grants and funding from Allergan, Bayer, Novartis, pSivida, Oraya, and Sakura. Dr. Kuppermann is involved in clinical research with Alcon, Alimera, Allegro, Allergan, Apellis, Genentech, GSK, J-Cyte, Neurotech, Ophthotech, Regen- eron, and ThromboGenics, and has been a consultant for Aerpio, Alcon, Alimera, Allegro, Allergan, Ampio, Dose, Genentech, Glaukos, Novartis, Ophthotech, Regeneron, and SciFluor. The authors thank Shuo Yang, PhD, of Quorum Consulting for statistical support. Medical writing assistance was provided by Emma Mycroft at Helios Medical Communications, supported by Alimera Sciences. Address correspondence to Michael A. Singer, MD, 9157 Huebner Rd., San Antonio, TX 78240; email: msinger11@me.com. doi: 10.3928/23258160-20180831-08

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