Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration

作者：Jean-François Korobelnik, Paolo Lanzetta, Sérgio Leal, Frank G. Holz, William L. Clark, David Eichenbaum, Tomohiro Iida, Xiaodong Sun, Alyson J. Berliner, Andrea Schulze, Min Zhao, Thomas Schmelter, Ursula Schmidt-Ott, Xin Zhang, Peter Morgan-Warren, Zoran Hasanbasic, Robert Vitti, Karen Chu, Kimberly Reed, Rafia Bhore, Yenchieh Cheng, Zhanying Bai, Boaz Hirshberg, George D. Yancopoulos, Tien Yin Wong · 发表于：Ophthalmology · 年份：2025 · DOI：10.1016/j.ophtha.2025.08.022 · 被引用次数：27 · 研究领域：Retinal Diseases and Treatments、Ophthalmology and Visual Impairment Studies、Retinal Imaging and Analysis

PURPOSE: To report the efficacy, durability, and safety of intravitreal aflibercept 8 mg versus intravitreal aflibercept 2 mg every 8 weeks (2q8) in patients with neovascular age-related macular degeneration (nAMD) through 96 weeks, PULSAR (ClinicalTrials.gov identifier, NCT04423718). DESIGN: Phase 3, randomized, noninferiority, 96-week trial. PARTICIPANTS: Treatment-naive adults ≥ 50 years with nAMD. METHODS: Patients were randomized 1:1:1 to intravitreal aflibercept 8 mg every 12 or 16 weeks (8q12 or 8q16), or 2q8, after 3 initial monthly doses; dosing intervals in 8-mg groups were modified based on prespecified criteria. MAIN OUTCOME MEASURES: Change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), proportion of patients maintaining or extending the randomized dosing intervals, and safety outcomes. RESULTS: Of 1009 patients treated, 869 patients (8q12, n = 291; 8q16, n = 292; 2q8, n = 286) completed treatment through week 96. Least squares (LS) mean change from baseline in BCVA at week 96 was +5.6 (95% confidence interval [Cl], 4.1-7.1), +5.5 (95% Cl, 4.0-7.0), and +6.6 (95% Cl, 5.2-8.0) letters in the 8q12, 8q16, and 2q8 groups, respectively; 8q12 and 8q16 differences versus 2q8 in LS mean BCVA changes at week 96 met the noninferiority criteria specified for the primary end point at week 48. Mean (standard deviation) change in CRT from baseline was -143.9 (123.6) μm, -153.4 (140.8) μm, and -135.8 (133.1) μm in the 8q12, 8q16, and 2...