A Phase 4 interventional study of avacincaptad pegol in Geographic Atrophy and Age-Related Macular Degeneration, sponsored by Astellas Pharma Inc. Active, not recruiting at 11 sites in Japan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Astellas Pharma Inc · Phase 4, Interventional, and Treatment
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.
IZERVAY has received marketing approval in Japan. The study will continue as a post marketing study in Japan.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
This study's enrollment of 17 is below the median of 70 across 141 interventional studies indexed under Geographic Atrophy.
Browse Geographic Atrophy studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participant is not pregnant and at least 1 of the following conditions apply:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Japan with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
Drug: avacincaptad pegol
intravitreal injection
Also known as: ASP3021, IZERVAY
Number of participants with Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. TEAEs are defined as an AE observed after first administration of ASP3021 until 30 days after final administration of ASP3021.
Time frame: Up to 12 Months
Number of participants with Serious TEAEs
A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations. TEAEs are defined as an AE observed after first administration of ASP3021 until 30 days after final administration of ASP3021.
Time frame: Up to 12 Months
Number of participants with intraocular pressure (IOP) abnormalities and/or AEs
Number of participants with potentially clinically significant IOP values.
Time frame: Up to 12 months
Number of participants with ophthalmic examination abnormalities and/or AEs
Number of participants with potentially clinically significant ophthalmic examination values.
Time frame: Up to 12 months
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 12 months
Number of participants with vital signs abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 12 months
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant 12-Lead ECG values.
Time frame: Up to 12 months
Mean rate of growth (slope) over 12 months
The growth (slope) over 12 months is estimated based on Geographic Atrophy (GA) area measured by fundus autofluorescence (FAF) (square root transformation).
Time frame: Up to 12 months
Change from baseline in best corrected visual acuity (BCVA)
BCVA will be measured by Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters chart.
Time frame: Baseline and up to 12 months
Change from baseline in low luminance best corrected visual acuity (LL BCVA)
LL BCVA will be measured by ETDRS letters chart.
Time frame: Baseline and up to 12 months
Number of participants with antidrug antibodies (ADA) status
ADA will be recorded from the serum samples collected.
Time frame: Up to 12 months
Number of participants with neutralizing antibodies (NAb) status for participant with positive ADA
NAb will be recorded from the serum samples collected.
Time frame: Up to 12 months
PK of ASP3021 in plasma: Concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Up to 2 months
Pharmacokinetics (PK) of ASP3021 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time frame: Up to 12 months
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Avacincaptad pegol