drugset / Trial / NCT04607148

A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

NCT04607148 ↗

Phase 2 Terminated 144 enrolled Genentech, Inc.
Non-randomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).

Timeline

Start
2020-11-16
Primary completion
2022-11-14
Completion
2022-11-14

Outcome

Outcome not reported

Stopped: “The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).”

Drugs

EvaluationDrugModalityDoseRoute
Subject Galegenimab Monoclonal antibody 10 mg Intravitreal
Subject Galegenimab Monoclonal antibody 20 mg Intravitreal