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

RECRUITINGPHASE4

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

NCT06970665•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.

Detailed Description

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

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant has non-foveal central point involvement geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
•Participant has total GA area ≥ 2.0 and ≤ 17.5 mm\^2 (1 and 7 disc areas \[DA\] respectively), determined by fundus autofluorescence (FAF) screening images.
•If participant has multifocal GA, at least one focal lesion should measure ≥ 1.25 mm\^2 (0.5 DA).
•Participant has GA in part within 1500 microns from the fovea center point.
•Participant has GA that must be able to be photographed in its entirety.
•Participant has best corrected visual acuity (BCVA) between 20/25 and 20/320, inclusive.
•Participant has clear ocular media and adequate pupillary dilatation in both eyes to allow for all imaging procedures, including good quality stereoscopic fundus photography and FAF.
•Participant has intraocular pressure (IOP) of ≤ 21 mmHg or less.
•Female participant is not pregnant and at least 1 of the following conditions apply:
•* Not a women of childbearing potential (WOCBP).
+8 more criteria

Exclusion Criteria

•Participant has evidence of choroidal neovascularization (CNV) in either eye.
•Participant has GA secondary to any condition other than AMD in the study eye (e.g., drug-induced).
•Participant has any ocular condition in the study eye that would progress during the course of the study and that could affect central vision or otherwise be a confounding factor.
•Participant has the presence or history of idiopathic or autoimmune-associated uveitis in either eye.
•Participant has significant media opacities, including cataract, which might interfere with visual acuity (VA), assessment of toxicity or retinal imaging (fundus photography, FAF, spectral domain optical coherence tomography \[SD-OCT\], enhanced depth imaging optical coherence tomography \[EDI OCT\], fluorescein angiography \[FA\] or indocyanine green angiography \[ICGA\]) in the course of the study in either eye. Participant should not be entered if there is likelihood that they will require cataract surgery in either eye during the study.
•Participant has the presence of other causes of CNV, including pathologic myopia, high myopia (spherical equivalent of -8 diopters or more, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis in either eye.
•Participant has any ocular or periocular infection (including blepharitis), or ocular surface inflammation in past 12 weeks in the study eye.
•Participant has any sign of diabetic retinopathy in either eye.
•Participant has BCVA of 20/320 or worse in the fellow eye.
•Participant has any prior treatment for AMD (dry or wet) or any prior intravitreal (IVT) treatment for any indication in either eye, except oral supplements of vitamins and minerals.
+14 more criteria

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

Key Dates

Start Date

July 8, 2025

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Geographic AtrophyAge-Related Macular Degeneration

Interventions

avacincaptad pegol

DRUG

Contacts

Astellas Pharma Inc.

CONTACT

+81-3-3244-6500 Japanese only astellas.registration@astellas.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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