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A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Led by Astellas Pharma Inc · Updated on 2026-02-27
20
Participants Needed
16
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (GA) secondary to age-related macular degeneration (AMD).
- Participant has total GA area between 2.0 and 17.5 mm² as determined by fundus autofluorescence screening.
- If participant has multifocal GA, at least one focal lesion measures 1.25 mm² or larger.
- Participant has GA within 1500 microns from the fovea center point.
- Participant's GA can be fully photographed.
- Participant has best corrected visual acuity (BCVA) between 20/25 and 20/320.
- Participant has clear ocular media and adequate pupil dilation for imaging in both eyes.
- Participant has intraocular pressure (IOP) of 21 mmHg or less.
- Female participants are not pregnant and meet specific conditions regarding childbearing potential and contraception.
- Female participants must not be breastfeeding or donating ova during and for 40 days after treatment.
- Male participants must use contraception or remain abstinent with partners of childbearing potential during and for 40 days after treatment.
- Male participants must not donate sperm during and for 40 days after treatment.
- Participant can return for all study visits for 12 months.
- Participant agrees not to participate in another interventional study during this study.
You will not qualify if you...
- Participant has choroidal neovascularization in either eye.
- Participant has GA due to causes other than AMD in the study eye.
- Participant has ocular conditions that may progress and affect central vision.
- Participant has intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, significant vitreomacular traction, vitreous hemorrhage, or aphakia in the study eye.
- Participant has current or past idiopathic or autoimmune-associated uveitis.
- Participant has media opacities like cataract that interfere with vision or imaging, or may need cataract surgery during the study.
- Participant has causes of CNV such as high myopia or ocular histoplasmosis syndrome.
- Participant has ocular or periocular infection or surface inflammation within 12 weeks in the study eye.
- Participant has diabetic retinopathy in either eye.
- Participant has BCVA of 20/320 or worse in the fellow eye.
- Participant has prior AMD treatment or intravitreal treatment except vitamin/mineral supplements.
- Participant is on medications toxic to the lens, retina, or optic nerve.
- Participant had intraocular surgery or thermal laser treatment in the study eye within 3 months prior to screening.
- Participant had certain eye surgeries like vitrectomy or corneal transplant in the study eye.
- Participant had therapeutic radiation near the study eye.
- Participant participated in previous ASP3021 studies.
- Participant has history or planned treatment with systemic anti-complement agents.
- Participant received investigational therapy within 60 days prior to screening.
- Participant has severe cardiac disease or peripheral vascular disease.
- Participant has significant kidney or liver impairment unless cleared by medical monitor.
- Participant had a stroke within 12 months.
- Participant had major surgery within 1 month prior to screening.
- Participant has conditions making them unsuitable for participation.
- Participant has serious allergies to dyes used in angiography, povidone-iodine, or ASP3021 components.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 16 locations
1
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
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2
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
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3
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
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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
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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
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12
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
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13
Nihon University Hospital
Chiyoda-ku, Tokyo, Japan
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14
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
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15
Toyama University Hospital
Toyama, Toyama, Japan
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16
University Of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan
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Research Team
A
Astellas Pharma Inc.
CONTACT
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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