A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision L… (NCT06970665) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Japan17 participantsStarted 2025-07-08
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
* WOCBP who has a negative serum pregnancy test at screening with a medical interview and agrees to follow the contraceptive guidance from the time of informed consent through at least 40 days after final study intervention administration.
* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 40 days after final study intervention administration.
* Female participant mus…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Treatment Emergent Adverse Events (TEAEs)