@article{6a596467bece4c3f9a862cdb44381189,
title = "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",
abstract = "BACKGROUND AND OBJECTIVE: Exploratory investigation 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 patients 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 (Quartiles 1 [P < .001] and 2 [P = .004]). Increases in NEI-VFQ-25 subscale scores correlated with AUC-CST/ day quartiles. BCVA significantly improved in patients 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.",
author = "Singer, {Michael A.} and Wykoff, {Charles C.} and Grewal, {Dilraj S.}",
note = "Funding Information: 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 interpretation 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{\textquoteright}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 Ophthalmology, 9157 Huebner Road, San Antonio, TX 78240; Tel: 210-269-3754; email: msinger11@me.com. doi: 10.3928/23258160-20201104-10 Publisher Copyright: {\textcopyright} 2020 Slack Incorporated. All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2020",
month = nov,
doi = "10.3928/23258160-20201104-10",
language = "English (US)",
volume = "51",
pages = "658--667",
journal = "Ophthalmic Surgery Lasers and Imaging Retina",
issn = "2325-8160",
publisher = "Slack Incorporated",
number = "11",
}