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RECRUITING
NCT06970665
PHASE4

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

Sponsor: Astellas Pharma Inc

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-07-08

Completion Date

2027-06-30

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

avacincaptad pegol

intravitreal injection

Locations (16)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

University of the Ryukyus hospital

Ginowan-shi, Okinawa, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

The University of Osaka Hospital

Suita-shi, Osaka, Japan

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan

Nihon University Hospital

Chiyoda-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Toyama University Hospital

Toyama, Toyama, Japan

University Of Yamanashi Hospital

Chuo-shi, Yamanashi, Japan