A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
NCT ID: NCT06970665
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2025-07-08
2027-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ASP3021
Participants in Japan with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
avacincaptad pegol
intravitreal injection
Interventions
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avacincaptad pegol
intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has total GA area ≥ 2.5 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 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 20/200 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.
40 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Associate Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
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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
Toyama University Hospital
Toyama, Toyama, Japan
University Of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan
Countries
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Central Contacts
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Other Identifiers
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jRCT2031250086
Identifier Type: REGISTRY
Identifier Source: secondary_id
3021-CL-3001
Identifier Type: -
Identifier Source: org_study_id