OSLI Retina

November 2020

Issue link: http://osliretina.healio.com/i/1309207

Contents of this Issue


Page 55 of 67

658 Ophthalmic Surgery, Lasers & Imaging Retina | Healio.com/OSLIRetina ■ B R I E F R E P O R T ■ Effects of Long-Term DME Control With 0.2 µg/Day Fluocinolone Acetonide Implant on Quality of Life: An Exploratory Analysis From the FAME Trial Michael A. Singer, MD; Charles C. Wykoff, MD; Dilraj S. Grewal, MD BACKGROUND AND OBJECTIVE: Exploratory inves- tigation of the effect of diabetic macular edema (DME) control with the 0.2 µg/day fluocinolone acetonide (FAc) intravitreal implant on quality of life (QOL) outcomes. PATIENTS AND METHODS: Post-hoc analysis of pa- tients from the FAME study who received the FAc implant and had answered the National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ-25) at baseline and Year 3 (N = 324). Patients were divided into quartiles (area under the curve [AUC]-central subfield thickness [CST]/day; n = 81/quartile). NEI- VFQ-25 and best-corrected visual acuity (BCVA) changes were analyzed per quartile during a period of 3 years. RESULTS: NEI-VFQ-25 scores were significantly higher in patients with low AUC-CST/day (Quar- tiles 1 [P < .001] and 2 [P = .004]). Increases in NEI- VFQ-25 subscale scores correlated with AUC-CST/ day quartiles. BCVA significantly improved in pa- tients with the lowest AUC-CST/day (Quartiles 1 and 2 [P < .001]). CONCLUSION: There was a positive and sustained correlation between the long-term control of DME and patient-reported QOL outcomes for up to 3 years following a single FAc implant in patients with controlled DME. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:658-667.] INTRODUCTION Diabetic macular edema (DME) is a major cause of vision impairment and blindness in patients with dia- betic retinopathy 1-4 and has a multifactorial pathogen- esis. 5,6 Hyperglycemia is a contributing factor to the pathogenesis of DME, leading to retinal neuroinflam- mation, oxidative stress, and vascular dysfunction. Evidence suggests that low-grade, chronic intraretinal inflammation serves as an early contributor to edema and pathogenic vascularization. 7 Therapeutic targets for DME typically work to control edema, which is determined by retinal thickness measurements (eg, central subfield thickness [CST]), and assessed using best-corrected visual acuity (BCVA), in order to deter- mine the functional outcomes of treatment. 8 From the Medical Center Ophthalmology Associates, San Antonio, Texas (MAS); Retina Consultants of Houston, Blanton Eye Institute & Houston Methodist Hospital, Houston, Texas (CCW); and Duke University School of Medicine, Durham, North Carolina (DSG). Originally submitted March 31, 2020. Revision received August 13, 2020. Accepted for publication September 3, 2020. Sponsored by Alimera Sciences. Alimera Sciences participated in the design and conduct of the studies; data collection, analysis, and inter- pretation of results; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. Dr. Singer had full access to all of the data in this study and takes complete responsibility for the integrity of the data and accuracy of the data analysis. Editorial assistance in the preparation of this article was provided by Rebecca Grayston, MRes, Helios Medical Communications (Alderley Edge, Cheshire, UK), which was funded by Alimera Sciences. Biostatistical analyses were provided by Alimera Sciences. Dr. Singer has received consulting fees from Aerie, Allegro, Allergan, EyePoint, Genentech, Kodiak, Novartis, Regeneron, and Santen; he has participated in a company-sponsored speaker's bureau for Allergan, Genentech, Mallinckrodt, Novartis, Regeneron, and Spark; he has received research support from Aerie, Allegro, Allergan, DRCR, Genentech, Icon, Ionis, KalVista, Kodiak, Novartis, Opthea, Optos, Regeneron, Santen, and Senju. Dr. Wykoff has received consulting fees from Adverum, Alimera Sciences, Allergan, Bayer, Chengdu Kanghong, Clearside Biomedical, Genentech/Roche, Kodiak, Novartis, Regeneron, and Regenxbio; he has received research support from Adverum, Allergan, Chengdu Kanghong, Clearside Biomedical, Genentech/Roche, Kodiak, Novartis, Opthea, Regeneron, Regenxbio, Samsung, and Xbrane Biopharma. Dr. Grewal has received consulting fees from Alimera Sciences, Clearside Biomedical, DORC, EyePoint, and Novartis. Address correspondence to Michael A. Singer, MD, Medical Center Oph- thalmology, 9157 Huebner Road, San Antonio, TX 78240; Tel: 210-269- 3754; email: msinger11@me.com. doi: 10.3928/23258160-20201104-10

Articles in this issue

Links on this page

Archives of this issue

view archives of OSLI Retina - November 2020