BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale.

Autor:	Hattenbach LO; Augenklinik des Klinikums Ludwigshafen, Ludwigshafen, Germany., Abreu F; Genentech, Inc., South San Francisco, California., Arrisi P; Roche Products Ltd., Welwyn Garden City, UK., Basu K; Roche Products (Ireland), Dublin, Ireland., Danzig CJ; Rand Eye Institute, Deerfield Beach, Florida.; Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida., Guymer R; The Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Australia., Haskova Z; Genentech, Inc., South San Francisco, California., Heier JS; Ophthalmic Consultants of Boston, Boston, Massachusetts., Kotecha A; Roche Products Ltd., Welwyn Garden City, UK., Liu Y; Genentech, Inc., South San Francisco, California., Loewenstein A; Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel., Seres A; Budapest Retina Associates, Budapest, Hungary., Willis JR; Genentech, Inc., South San Francisco, California., Wykoff CC; Retinal Consultants of Texas, Houston, Texas., Paris LP; Genentech, Inc., South San Francisco, California.
Jazyk:	angličtina
Zdroj:	Ophthalmology science [Ophthalmol Sci] 2023 Mar 27; Vol. 3 (3), pp. 100302. Date of Electronic Publication: 2023 Mar 27 (Print Publication: 2023).
DOI:	10.1016/j.xops.2023.100302
Abstrakt:	Purpose: Dual inhibition of angiopoietin-2 and VEGF-A with faricimab (Vabysmo) offers excellent visual acuity gains with strong durability in patients with diabetic macular edema (ME) and neovascular age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy, safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO). Design: Two identically designed global, randomized, double-masked, active comparator-controlled studies. Participants: Anti-VEGF treatment-naive patients with branch, central, or hemiretinal RVO. Methods: Patients were randomized to 6 monthly injections of faricimab 6.0 mg or aflibercept 2.0 mg. From weeks 24 to 72, all patients received faricimab 6.0 mg administered in up to 16-week intervals using an automated treatment algorithm to generate a treat-and-extend-based personalized treatment interval dosing regimen. Personalized treatment interval adjustments were based on changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA). Main Outcome Measures: Primary end point was noninferiority of faricimab versus aflibercept in mean change from baseline in BCVA (week 24; noninferiority margin: 4 letters). Secondary end points (weeks 0-24) were mean change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire 25 composite score; proportion of patients gaining or avoiding loss of ≥ 15/≥ 10/≥ 5/> 0 letters. Secondary end points (weeks 24-72) were treatment durability (week 68); continuation of weeks 0 to 24 end points. Ocular/nonocular adverse events will be assessed. Results: In total, 1282 patients across 22 countries were enrolled (BALATON, 553 patients, 149 centers; COMINO, 729 patients, 193 centers). Conclusions: Using a novel automated interval algorithm, BALATON/COMINO will evaluate the efficacy and safety of faricimab for ME secondary to RVO and provide key insights into how to personalize treatment. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. (© 2023 by the American Academy of Ophthalmology.)
Databáze:	MEDLINE
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