American journal of ophthalmology · 2025
Phase 2 Study of the Anti-High Temperature Requirement A1 (HtrA1) Fab Galegenimab (FHTR2163) in Geographic Atrophy Secondary to Age-Related Macular Degeneration.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Eichenbaum David A, Holekamp Nancy, Khanani Arshad M, Pieramici Dante, Hershberger Vrinda, Sheth Veeral, Brunstein Flavia, Ma Ling, Zou Yixuan, Indjeian Vahan B, Dere Randall, Maia Mauricio, Hsu Joy C, Gao Simon S, Yaspan Brian, Willis Jeffrey R, Wiley Henry, Lai Phillip, Chen Hao
Аннотация
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 mm2 in the study eye were enrolled. Patients were randomized 2:1:2 to receive 20 mg galegenimab every 4 (Q4W) or 8 weeks (Q8W), or sham Q4/8 W. The primary endpoint was mean change in GA area from baseline to Week 72 measured by fundus autofluorescence. A data monitoring committee (DMC) conducted periodic unmasked review of cumulative safety/limited efficacy data of the ongoing study.
RESULTS: Among 337 patients who received ≥ 1 dose and have at least one postbaseline GA area measurement, the adjusted mean change in GA area from baseline to Week 72 was 2.67, 2.50, and 2.38 mm2 for the galegenimab Q4W, galegenimab Q8W, and pooled sham arms, respectively. Differences between the treated and sham groups were not statistically significant. However, the rate of intraocular inflammation was high (7.1%, 16/224 patients) among treated patients. The DMC recommended early termination of the study based on an early benefit/risk analysis.
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.
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 mm2 in the study eye were enrolled. Patients were randomized 2:1:2 to receive 20 mg galegenimab every 4 (Q4W) or 8 weeks (Q8W), or sham Q4/8 W. The primary endpoint was mean change in GA area from baseline to Week 72 measured by fundus autofluorescence. A data monitoring committee (DMC) conducted periodic unmasked review of cumulative safety/limited efficacy data of the ongoing study.
RESULTS: Among 337 patients who received ≥ 1 dose and have at least one postbaseline GA area measurement, the adjusted mean change in GA area from baseline to Week 72 was 2.67, 2.50, and 2.38 mm2 for the galegenimab Q4W, galegenimab Q8W, and pooled sham arms, respectively. Differences between the treated and sham groups were not statistically significant. However, the rate of intraocular inflammation was high (7.1%, 16/224 patients) among treated patients. The DMC recommended early termination of the study based on an early benefit/risk analysis.
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.
Предметные рубрики MeSH
HumansMaleGeographic AtrophyFemaleIntravitreal InjectionsAgedVisual AcuityHigh-Temperature Requirement A Serine Peptidase 1Single-Blind MethodFluorescein AngiographyAged, 80 and overAntibodies, Monoclonal, HumanizedTomography, Optical CoherenceImmunoglobulin Fab FragmentsTreatment OutcomeMacular DegenerationMiddle Aged