OSLI Retina

May 2020

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298 Ophthalmic Surgery, Lasers & Imaging Retina | Healio.com/OSLIRetina Reduction in Retinal Thickness Fluctuations After Treatment With Fluocinolone Acetonide Implant for DME: A Post-Hoc Analysis of the USER Study Christopher D. Riemann, MD; Alexander M. Eaton, MD; Antonio Cutino, COT BACKGROUND AND OBJECTIVE: Assess fluocinolone acetonide implant (FAc) effects on diabetic macu- lar edema (DME) retinal thickness fluctuations. PATIENTS AND METHODS: A post-hoc chart review of the real-world USER study analyzed patients re- ceiving 0.2 μg/day FAc implant. The percentage of eyes with central subfield thickness (CST) of 300 μm or less were compared pre- and post-FAc implant; mean retinal thickness amplitude (RTA), retinal thickness standard deviation (RTSD), and two case studies were analyzed. RESULTS: One hundred thirty patients (mean age: 69.6 years) presented; CST was available for 120 of 160 treated eyes. Mean RTA decreased signifi- cantly post-FAc implant (P < .001) regardless of baseline visual acuity (VA). Correlations with last- observed VA (R 2 ) were: RTA, 0.1197; retinal thick- ness standard deviation (RTSD), 0.1526; and area under the CST-time curve (AUC CST), 0.0981. Af- ter FAc implant, the percentage of eyes with CST of 300 μm or less was significantly greater versus baseline (P < .05). CONCLUSIONS: Retinal thickness fluctuations sig- nificantly declined after FAc and correlated with improvement in VA. Both RTSD and RTA mea- sures correlated more closely to last observed VA than AUC CST itself. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:298-306.] INTRODUCTION Diabetic macular edema (DME) is the leading cause of vision loss in patients with diabetic retinopa- thy. 1 During the past decade, evidence has emerged to suggest that chronic, low-grade intraretinal inflamma- tion secondary to hyperglycemia in diabetes serves as a critical early contributor to the development of edema and pathogenic vascularization in diabetic patients. 2,3 A variety of DME treatment options are available, including laser photocoagulation, anti- vascular endothelial growth factor (VEGF), ste- roids, and surgical therapy, 4 with anti-VEGF being the first-line treatment option. 5,6 However, many patients have a suboptimal response or are nonre- sponders to anti-VEGF therapy, 7,8 with deteriorat- ing clinical outcomes over time, often because of From the Cincinnati Eye Institute, Cincinnati, Ohio (CDR); Retina Health Center, Fort Myers, Florida (AEM); and Alimera Sciences, Alpharetta, Georgia (AC). © 2020 Riemann, Eaton, Cutino; licensee SLACK Incorporated. This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International (https://creativecommons.org/licenses/by/4.0). This license allows users to copy and distribute, to remix, transform, and build upon the article, for any purpose, even commercially, provided the author is attributed and is not represented as endorsing the use made of the work. Originally submitted January 23, 2020. Revision received April 1, 2020. Accepted for publication April 2, 2020. Study sponsorship and article processing charges funded by Alimera Sciences. Editorial assistance in the preparation of this article was provided by Helios Med- ical Communications, Alderley Edge Cheshire, UK. Support for this assistance was funded by Alimera. Biostatistical analyses were provided by Alimera. Hus- sein Wafapoor, MD, Fort Myers, Florida, was an investigator in the USER study. Dr. Riemann has received personal fees for consultancy and speaking from Al- con, Alimera, Bausch + Lomb/Valeant; personal fees for consultancy from BMC/ Eyetube; speaker fees from Alcon, Allergan, Novartis, and Regeneron; and is a partial owner of Northmark Pharmacy. He also reports receiving monies for re- search from AGTC, Alcon, Alimera, Allergan, Aerpio, BioTime/Lineage, Chengdu Kanghong, Clearside, Genentech/Roche, Gyroscope, Lineage/Biotime, Janssen/ Johnson & Johnson, Lowry-MacTel Registry, Neurotech, Nightstar/Biogen, Notal Vision, Novartis, Ophthotec/Iveric, Regeneron, and Spark. Dr. Eaton reports a relationship with Alimera Sciences during the conduct of the study and received personal fees from Alimera Sciences outside the submitted work; he also reports stock ownership in Alimera Sciences, pSivida, and Regeneron. Mr. Cutino is an employee and holds stocks and shares in Alimera Sciences. The authors would like to thank all of the participants of the USER study. Address correspondence to Christopher D. Riemann, MD, Cincinnati Eye Insti- tute, 1945 CEI Drive, Cincinnati, OH 45242; email: Criemann@cvphealth.com. doi: 10.3928/23258160-20200501-09 ■ B R I E F R E P O R T ■

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