NCT04656561

A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy

A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Masked, 4-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) - The ARCHER Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Annexon, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) to determine if intravitreal (IVT) injections of ANX007 reduce GA lesion growth rate. The results will be used to guide further development of ANX007 in participants with geographic atrophy. The total duration of participation is expected to be approximately 19 months.

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	ANX007	Form: solution for injection; Route of Administration: IVT
OTHER	Sham comparator	Form and Route of Administration: pressure to mimic IVT injection

Timeline

• Start date: 2021-02-26
• Primary completion: 2023-03-28
• Completion: 2023-09-13
• First posted: 2020-12-07
• Last updated: 2024-08-21

Locations

53 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study