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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration (NCT06970665) is a Phase 4 interventional studying Geographic Atrophy and Age-Related Macular Degeneration, sponsored by Astellas Pharma Inc. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 must not donate ova starting at first administration of study intervention and throughout the investigational period and for 40 days after final study intervention administration. - Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 40 days after final study intervention administration. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 must not donate ova starting at first administration of study intervention and throughout the investigational period and for 40 days after final study intervention administration. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 40 days after final study intervention administration. * Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 40 days after final study intervention administration. * Male participant must not donate sperm during the treatment period and for 40 days after final study intervention administration. * Participant has ability to return for all study visits for the 12-month duration of the study. * Participant agrees not to participate in another interventional study while participating in the present study. 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 of intraocular inflammation (≥ trace cell or flare), macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreomacular traction, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria) in the study eye. * 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. * Participant has concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina, or optic nerve in either eye (including, but not limited to amiodarone, deferoxamine, chloroquine/hydroxychloroquine sulfate, tamoxifen, phenothiazines, ethambutol or fingolimod). * Participant has had any intraocular surgery or thermal laser treatment in the study eye within 3 months prior to screening, or any prior thermal laser treatment in the macular region, regardless of indication in the study eye. * Participant has a history of any of the following procedures in the study eye: posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant, or retinal detachment. * Participant has any previous therapeutic radiation in the region of the study eye. * Participant has a present or previous history of participation in a study of ASP3021. * Participant has a history of systemic treatment with any anti-complement agent in past or the likelihood of treatment with any systemic anti-complement agent during the study. * Participant has received any investigational therapy within 60 days or 5 half-lives, whichever is longer, prior to screening. * Participant has a history or evidence of severe cardiac disease (e.g., New York Heart Association \[NYHA\] Functional Class III or IV, or history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, or ventricular tachyarrhythmias requiring ongoing treatment. * Participant has a history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation. * Participant has clinically significant impaired renal (serum creatinine \> 2.5 mg/dL or status post-renal transplant or receiving dialysis) or hepatic function. Participants with these conditions may be enrolled after consultation with the medical monitor. * Participant has a history of stroke within 12 months prior to screening. * Participant has had any major surgical procedure within 1 month prior to screening. * Participant has any condition that makes the participant unsuitable for study participation. * Participant has a known or suspected serious allergy to the fluorescein dye and/or the indocyanine green dye used in angiography, povidone-iodine or hypersensitivity to ASP3021 or any components of the formulation used.

Treatments Being Tested

DRUG

avacincaptad pegol

intravitreal injection

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06970665), the sponsor (Astellas Pharma Inc), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06970665 clinical trial studying?

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 w… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06970665?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06970665?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06970665. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06970665. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.