A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
Summary
This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.
Timeline
- Start
- 2019-06-03
- Primary completion
- 2022-10-27
- Completion
- 2022-10-27
Outcome
Missed primary endpoint
Stopped: “The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).”
registry analysis (superiority test); Galegenimab Q4W vs All Sham; p = 0.1206; Difference in Adjusted Means 0.29 (95% CI -0.08 to 0.66); MMRM NCT03972709 ↗
registry analysis (superiority test); Galegenimab Q8W vs All Sham; p = 0.6127; Difference in Adjusted Means 0.12 (95% CI -0.34 to 0.57); MMRM NCT03972709 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Galegenimab | Monoclonal antibody | — | Intravitreal |