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A Phase 3/4 Multicenter Study Assessing Safety of Intravitreal ASP3021 in Japanese Participants with Geographic Atrophy from Age-Related Macular Degeneration
Led by Astellas Pharma Inc · Updated on 2026-02-27
20
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Age-related macular degeneration (AMD) is an eye condition that gradually causes vision loss by damaging the macula, the central part of the retina responsible for clear vision. This trial focuses on adults aged 40 years or older in Japan who have geographic atrophy (GA), a severe form of AMD. The study aims to gather information about the safety and tolerability of ASP3021, a treatment given by injection into the affected eye. Participants will receive monthly intravitreal injections of ASP3021 for 12 months. This treatment involves injecting the drug directly into the eye. The study is a single-arm trial conducted after the marketing approval of IZERVAY in Japan, continuing as a post-marketing study. During the 12-month study period, participants will visit the clinic several times for health assessments, including eye exams and imaging. Researchers will monitor safety by tracking treatment-emergent adverse events and other eye-related changes. Vision and other health measures will be recorded to evaluate participants' responses to the treatment throughout the study.
CONDITIONS
Brief Title
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has non-foveal central point involvement geographic atrophy secondary to age-related macular degeneration.
- Total geographic atrophy area between 2.0 and 17.5 mm² as determined by fundus autofluorescence.
- For multifocal geographic atrophy, at least one lesion measures 1.25 mm² or more.
- Geographic atrophy located within 1500 microns from the fovea center.
- Geographic atrophy can be fully photographed.
- Best corrected visual acuity between 20/25 and 20/320 inclusive.
- Clear ocular media and adequate pupil dilation in both eyes for imaging.
- Intraocular pressure of 21 mmHg or less.
- Female participants not pregnant and either not women of childbearing potential or have negative pregnancy test and agree to contraception.
- Female participants not breastfeeding or donating ova during study and for 40 days after final treatment.
- Male participants agree to contraception or abstinence during treatment and for 40 days after.
- Ability to attend all study visits for 12 months.
- Agree not to join another interventional study during this study.
You will not qualify if you...
- Evidence of choroidal neovascularization in either eye.
- Geographic atrophy caused by conditions other than age-related macular degeneration.
- Ocular conditions in study eye that may progress or affect central vision.
- Presence of intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, significant vitreomacular traction, vitreous hemorrhage, or aphakia in study eye.
- History or presence of idiopathic or autoimmune-associated uveitis in either eye.
- Significant media opacities or cataract that could interfere with vision or imaging.
- Other causes of choroidal neovascularization like ocular histoplasmosis or angioid streaks.
- Ocular or periocular infection or inflammation within past 12 weeks.
- Signs of diabetic retinopathy in either eye.
- Best corrected visual acuity of 20/320 or worse in the fellow eye.
- Prior treatment for AMD or prior intravitreal treatment except vitamin or mineral supplements.
- Use of ocular or systemic medications toxic to eye structures.
- Recent intraocular surgery or thermal laser treatment.
- History of certain eye surgeries like vitrectomy or corneal transplant.
- Prior therapeutic radiation near study eye.
- Previous participation in ASP3021 studies.
- Systemic anti-complement agent treatment.
- Recent investigational therapy use.
- Severe cardiac disease or clinically significant peripheral vascular disease.
- Significant kidney or liver impairment unless approved.
- Stroke within 12 months before screening.
- Major surgery within 1 month before screening.
- Any condition making participation unsuitable.
- Known allergy to dyes used in eye imaging or to ASP3021 components.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive intravitreal injections of ASP3021 to assess safety and potential benefits on vision loss from geographic atrophy related to age-related macular degeneration.
Regular visits for injections and assessments during treatment
Trial Site Locations
Total: 16 locations
1
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Actively Recruiting
2
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Actively Recruiting
3
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Actively Recruiting
4
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
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5
Kyoto University Hospital
Kyoto, Kyoto, Japan
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6
Mie University Hospital
Tsu, Mie-ken, Japan
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7
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Actively Recruiting
8
University of the Ryukyus hospital
Ginowan-shi, Okinawa, Japan
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9
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
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10
The University of Osaka Hospital
Suita-shi, Osaka, Japan
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11
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Actively Recruiting
12
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
Actively Recruiting
13
Nihon University Hospital
Chiyoda-ku, Tokyo, Japan
Actively Recruiting
14
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Actively Recruiting
15
Toyama University Hospital
Toyama, Toyama, Japan
Actively Recruiting
16
University Of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan
Actively Recruiting
Research Team
A
Astellas Pharma Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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