NCT05536297

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 23 visit on study treatment (either avacincaptad pegol or Sham).

Conditions

• Geographic Atrophy
• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	avacincaptad pegol	Intravitreal Injection

Timeline

• Start date: 2022-09-26
• Primary completion: 2025-04-10
• Completion: 2025-04-10
• First posted: 2022-09-10
• Last updated: 2026-04-14
• Results posted: 2026-04-14

Locations

117 sites across 17 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Latvia, Spain

Regulatory

• FDA-regulated drug study