New eye injection aims to slow vision loss from Age-Related macular degeneration
NCT ID NCT06970665
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This study tests the safety of a drug called ASP3021 (avacincaptad pegol) for people in Japan with geographic atrophy, an advanced form of age-related macular degeneration that causes vision loss. Twenty participants will receive monthly injections into the affected eye for 12 months. The main goal is to see if the treatment is safe and well-tolerated.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- avacincaptad pegol (ASP3021, IZERVAY)
- What this could lead to
- If successful, this could confirm that ASP3021 is safe for Japanese patients with geographic atrophy, potentially slowing vision loss.
- What could go wrong
- This is a small, single-arm safety study with only 20 participants, so results may not apply broadly. Side effects from eye injections are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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17 people
The number who actually took part.
- Started
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Jul 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
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Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
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Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
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Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
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Kyoto University Hospital
Kyoto, Kyoto, Japan
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Mie University Hospital
Tsu, Mie-ken, Japan
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Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
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Nihon University Hospital
Chiyoda-ku, Tokyo, Japan
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Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
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The University of Osaka Hospital
Suita-shi, Osaka, Japan
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Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
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Toyama University Hospital
Toyama, Toyama, Japan
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University Of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan
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University of the Ryukyus hospital
Ginowan-shi, Okinawa, Japan
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Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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