NCT03972709

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

A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Degeneration, Age-Related
• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	Galegenimab	Intravitreal (ITV) injections of galegenimab
DRUG	Sham Control	Sham control

Timeline

• Start date: 2019-06-03
• Primary completion: 2022-10-27
• Completion: 2022-10-27
• First posted: 2019-06-04
• Last updated: 2024-03-27
• Results posted: 2024-03-27

Locations

72 sites across 1 country: United States

Regulatory

• FDA-regulated drug study