Phase 2 Study of the Anti-High Temperature Requirement A1 (HtrA1) Fab Galegenimab (FHTR2163) in Geographic Atrophy Secondary to Age-Related Macular Degeneration.

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Tác giả: Flavia Brunstein, Hao Chen, Randall Dere, David A Eichenbaum, Simon S Gao, Vrinda Hershberger, Nancy Holekamp, Joy C Hsu, Vahan B Indjeian, Arshad M Khanani, Phillip Lai, Ling Ma, Mauricio Maia, Dante Pieramici, Veeral Sheth, Henry Wiley, Jeffrey R Willis, Brian Yaspan, Yixuan Zou

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: United States : American journal of ophthalmology , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 714178

PURPOSE: To investigate the safety, tolerability, and efficacy of intravitreal injection of galegenimab, an anti-HtrA1 FAb, in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). DESIGN: Phase 2, single-masked, randomized clinical trial. METHODS: Eligible GA patients with BCVA letter scores of ≥ 24 letters and baseline GA lesion size 2.54∼25.4 mm RESULTS: Among 337 patients who received ≥ 1 dose and have at least one post-baseline GA area measurement, the adjusted mean change in GA area from baseline to Week 72 was 2.67, 2.50, and 2.38 mm CONCLUSION: Galegenimab administration did not show a difference in mean change in GA area from baseline to Week 72 compared with sham. Inhibition of HtrA1 with a Fab did not slow down GA progression.
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