학술논문
BETTER BASELINE VISION LEADS TO BETTER OUTCOMES AFTER THE 0.19-mg FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT IN DIABETIC MACULAR EDEMA
Document Type
Academic Journal
Author
Gonzalez, Victor H.; Luo, Caesar; Almeida, David R.P.; Cutino, Antonio; Coughlin, Brandon; Kasper, Jonathan; Kiernan, Daniel F.; Abdelsalam, Ahmed; Shakoor, Akbar; Moshiri, Ala; Barkmeier, Andrew; Tewari, Asheesh; Baker, Carl; Kiernan, Daniel; Rosberger, Daniel; Roth, Daniel; Eichenbaum, David; Malik, Deepika; Marcus, Dennis; Dehning, Doug; Reichel, Elias; Tilton, Elisha; Fu, Evelyn; Kokame, Gregg; Salehi-Had, Hani; Bhatt, Harit; Nielsen, Jared; Prensky, Jay; Lim, Jennifer; Adleberg, Jon; Beck, Joseph; Gunn, Joseph; Podhorzer, Joseph; Small, Kent; Kooragayala, Lakshmana; Freisberg, Lars; Schocket, Lisa; Berrocal, Maria; Worrall, Martin; Cassell, Michael; Singer, Michael; Tsipursky, Michael; Holekamp, Nancy; Weber, Pamela; Merrill, Pauline; Campochiaro, Peter; Dugel, Pravin; Khurana, Rahul; Apte, Rajendra; Rathod, Rajiv; Katz, Randy; Chace, Richard; Kwun, Robert; Grigorian, Ruben; Mansour, Sam; Chexal, Saradha; Madreperla, Steven; Gonzalez, Victor; Aldred, William
Source
Retina. Aug 01, 2023 43(8):1301-1307
Subject
Language
English
ISSN
0275-004X
Abstract
PURPOSE:: Analysis of a 3-year, Phase 4, open-label, observational study evaluating the association of baseline best-corrected visual acuity (BCVA) with visual, treatment burden, and retinal thickness variability (RTV) outcomes and intraocular pressure (IOP)-related events after the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant. METHODS:: Data from patients with diabetic macular edema (DME) who did not have a clinically significant rise in IOP after previous corticosteroid treatment (N = 202 eyes from 159 patients) were segregated by baseline BCVA of ≥20/40 or <20/40 and analyzed for BCVA, number of yearly supplemental DME treatments, RTV, and incidence of IOP-related events. RESULTS:: At 36 months post-FAc, eyes with better baseline BCVA (≥20/40) maintained baseline BCVA, whereas vision in eyes with worse baseline BCVA (<20/40) increased by approximately 7 letters to 61.34 letters (Snellen equivalent approximately 20/60; P < 0.05). Treatment burden and RTV decreased post-FAc regardless of baseline BCVA. Eyes with better baseline BCVA (≥20/40) had numerically fewer IOP-related events post-FAc versus eyes with worse baseline BCVA (<20/40), including a lower incidence of incisional IOP-lowering surgery. CONCLUSION:: The 0.19-mg FAc implant improved RTV and treatment burden regardless of baseline BCVA. Better baseline BCVA (≥20/40) was associated with long-term BCVA maintenance. Although eyes with worse baseline BCVA (<20/40) experienced significantly improved BCVA, it never rose to the level of those with better baseline BCVA. These data indicate that early, effective intervention in DME, before significant vision loss occurs, is key to maintaining visual outcomes.