ClinicalTrials.gg
Active, not recruitingNCT06970665Updated Oct 30, 2026

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

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

Updated Oct 30, 20265 sites removedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

IZERVAY has received marketing approval in Japan. The study will continue as a post marketing study in Japan.

02

Conditions studied

  • Geographic Atrophy
  • Age-Related Macular Degeneration

Keywords

  • avacincaptad pegol
  • IZERVAY
  • ASP3021
03

In context

Geographic Atrophy

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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 (WOCBP).
    • WOCBP who has a negative serum pregnancy test at screening with a medical interview and agrees to follow the guidance from the time of through at least 40 days after final study intervention administration.
  • Female participant must not be breastfeeding or lactating starting at screening and throughout the 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

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 -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 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., [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 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 to ASP3021 or any components of the formulation used.
Terms in these criteria, in plain language(8)

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.

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.

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.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

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.

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    ASP3021

    Participants in Japan with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration

    Drug: avacincaptad pegol

Interventions

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Number of participants with antidrug antibodies (ADA) status

    ADA will be recorded from the serum samples collected.

    Time frame: Up to 12 months

  10. 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

  11. PK of ASP3021 in plasma: Concentration

    Concentration will be recorded from the PK plasma samples collected.

    Time frame: Up to 2 months

  12. 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

07

Study locations

11 sites
08

References and documents

Individual participant data

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.

09

Updates

2 registry updates since Sep 25, 2026
Sites
5 sites removed
Show 5 removed
  • Mie University Hospital · Tsu, Japan
  • Seirei Hamamatsu General Hospital · Hamamatsu, Japan
  • Nagoya City University Hospital · Nagoya, Japan
  • Jichi Medical University Hospital · Shimotsuke-shi, Japan
  • Tokyo Women's Medical University Hospital · Shinjuku-ku, Japan
across 2 updates, Sep 30, 2026 – Oct 30, 2026
Show all 2 updates
  1. Oct 30, 2026
    3 sites removed
    Show 3 removed
    • Nagoya City University Hospital · Nagoya, Japan
    • Jichi Medical University Hospital · Shimotsuke-shi, Japan
    • Tokyo Women's Medical University Hospital · Shinjuku-ku, Japan
    + 1 other change: verification date
  2. Sep 30, 2026
    2 sites removed
    Show 2 removed
    • Mie University Hospital · Tsu, Japan
    • Seirei Hamamatsu General Hospital · Hamamatsu, Japan

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 ↗

10

Registry details

Key details

Study ID
NCT06970665
Responsible party
Sponsor
First posted
May 14, 2025
Start date
Jul 8, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Associate Medical Director
study director · Astellas Pharma Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Avacincaptad pegol

Start the discussion