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PREDICTORS OF ONE-YEAR VISUAL OUTCOMES AFTER ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR TREATMENT FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Kodjikian, Laurent, MD, PhD*,†,‡; Decullier, Evelyne, PhD†,§,¶; Souied, Eric H., MD, PhD**,††; Roux, Adeline, MSc§; Aulagner, Gilles, PharmD, PhD†,‡,‡‡,§§; Huot, Laure, PharmD, PhD†,§,¶ for the GEFAL Study Group

doi: 10.1097/IAE.0000000000001736
Original Study

Purpose: To determine predictors of best-corrected visual acuity (BCVA) outcomes 1 year after ranibizumab or bevacizumab treatment for neovascular age-related macular degeneration, within the French Study Group Avastin versus Lucentis for neovascular age-related macular degeneration (GEFAL).

Methods: Patients aged ≥50 years presenting subfoveal neovascular age-related macular degeneration were randomized to receive ranibizumab or bevacizumab (3 monthly intravitreal injections followed by an as-needed regimen). The main outcome measures were BCVA and its change from baseline at 1 year. Variables with a P value <0.20 in the univariate model and/or which were clinically relevant were included in the multivariate analysis.

Results: The following baseline factors were associated with a lower BCVA score at 1 year and with less improvement in BCVA (multivariate analysis): intraretinal fluid, thickness of central subfield macular ≤277 μm, predominantly classic choroidal neovascularization, and total area of choroidal neovascularization (all P ≤ 0.01). Pigment epithelium detachment and high baseline BCVA were associated with less improvement in BCVA (P = 0.03, P = 0.05, respectively). Patients who met retreatment criteria but did not receive the corresponding injection had significantly poorer outcomes (only tested in the univariate analysis).

Conclusion: This study confirms the predictors of BCVA score at 1 year posttreatment; the presence of intraretinal fluid was associated with a poor prognosis.

Baseline predictors of a lower best-corrected visual acuity score at 1 year and with less improvement in best-corrected visual acuity were studied on data from patients included in GEFAL, a multicenter, noninferiority, double-masked randomized trial in neovascular age-related macular degeneration.

*Hospices Civils de Lyon, Groupement Hospitalier Nord, Hôpital de la Croix-Rousse, Service d'ophtalmologie, Lyon, France;

Université de Lyon, Lyon, France;

Mateis, CNRS UMR 5510, Villeurbanne, France;

§Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, Unité de recherche clinique, Lyon, France;

Université Lyon 1, EAM 4128 P2S, Lyon, France;

**Centre Hospitalier Intercommunal de Créteil, Service d'ophtalmologie, Créteil, France;

††Université Paris Est Créteil, CRC, Créteil, France;

‡‡Hospices Civils de Lyon, Groupement Hospitalier Est, Service Pharmaceutique, Bron, France; and

§§Université Lyon 1, Institut des Sciences Pharmaceutiques et Biologiques, Faculté de Pharmacie, Lyon, France.

Reprint requests: Laurent Kodjikian, MD, PhD, Hospices Civils de Lyon, Groupement Hospitalier Nord, Hôpital de la Croix-Rousse, Service d'ophtalmologie, 103 Grande Rue de la Croix-Rousse F-69317, Lyon Cedex 04, France; e-mail: laurent.kodjikian@chu-lyon.fr

Supported by a grant from the French Ministry of Health (“Programme Hospitalier de Recherche Clinique National 2008 number 27-29”); the French Health Insurance System cofinanced the study and funded the drugs. The funding organizations had no role in designing or carrying out this research.

Club Jules Gonin, Zurich, September 4, 2014, Switzerland & Euretina congress, Nice, France, September 18, 2015.

L. Kodjikian: Principal Investigator for trials sponsored by Novartis, Théa, Alcon; has sat on advisory boards for Alcon, Alimera, Allergan, Bayer, Novartis, Théa; lecture fees from Alcon, Allergan, Bayer, Novartis, Théa. E. H. Souied: Honoraria from Novartis, Bayer, Allergan; has sat on advisory boards for Théa; consulting fees from Novartis, Bayer, Allergan. The remaining authors have no conflicting interests to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.retinajournal.com).

The GEFAL Study Group members are listed in Supplemental Digital Content 1, http://links.lww.com/IAE/A669.

© 2018 by Ophthalmic Communications Society, Inc.