NCT06510816

A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Geographic Atrophy (GA)

A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 659 (actual)
• Sponsor: Annexon, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with GA secondary to age-related macular degeneration (AMD).

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	Vonaprument	Form: solution for injection; Route of Administration: IVT injection
OTHER	Sham Administration	Form and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection).

Timeline

• Start date: 2024-07-30
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2024-07-19
• Last updated: 2025-11-06

Locations

130 sites across 14 countries: United States, Australia, Austria, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study