NCT06970665

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

A Phase 3/4, Multicenter, Single-arm Clinical Study to Assess the Safety of Intravitreal Administration of ASP3021 in Participants in Japan With Geographic Atrophy Secondary to Age-related Macular Degeneration

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Age-related macular degeneration (AMD) is an eye disease which causes people to lose their vision over time. AMD damages the macula, which is in the middle of the retina - the light sensitive part at the back of the eye. In AMD, the cells in the macula die over time, usually over several years, leading to vision loss. When AMD gets worse, it can turn into either geographic atrophy (GA), neovascular AMD, or both. This study is for people in Japan of 40 years of age or older, who have geographic atrophy. The main aim of this study is to collect information about the safety of ASP3021 and how well people tolerate treatment with ASP3021. During the study, people will receive monthly injections of ASP3021 for 12 months. ASP3021 is given by injection into the affected eye. This procedure is called an intravitreal injection. People will be in the study for about 1 year. People will visit their study clinic several times for health checks.

Detailed description

IZERVAY has received marketing approval in Japan. The study will continue as a post marketing study in Japan.

Conditions

• Geographic Atrophy
• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	avacincaptad pegol	intravitreal injection

Timeline

• Start date: 2025-07-08
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-05-14
• Last updated: 2026-02-27

Locations

16 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study