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Geographic AtrophyPhase 4NCT06970665

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 study testing avacincaptad pegol in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Astellas Pharma Inc at 11 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
avacincaptad pegol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
11 sitesJapan
Study dates
8 Jul 2025to 30 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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 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.
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  • 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 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Japan11 sites

  • Nihon University Hospital

    Chiyoda-ku, Tokyo

  • University Of Yamanashi Hospital

    Chuo-shi, Yamanashi

  • Fukushima Medical University Hospital

    Fukushima, Fukushima

  • University of the Ryukyus hospital

    Ginowan-shi, Okinawa

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken

  • Kyoto University Hospital

    Kyoto, Kyoto

  • Nagasaki University Hospital

    Nagasaki, Nagasaki

  • The University of Osaka Hospital

    Suita-shi, Osaka

  • Toyama University Hospital

    Toyama, Toyama

  • Yokohama City University Medical Center

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase 3/4, Multicenter, Single-arm Clinical Study to Assess the Safety of Intravitreal Administration of ASP3021 in Participants in Japan With Geographic Atrophy Secondary to Age-related Macular Degeneration

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.

Read more

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.

Being tested
avacincaptad pegol
Keywords
avacincaptad pegol, IZERVAY, ASP3021
Medical subject headings
Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • avacincaptad pegolDrug

    Also called ASP3021, IZERVAY

    intravitreal injection

Study groups in NCT06970665
Study groupRoleWhat they receive
ASP3021ExperimentalParticipants in Japan with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
Receives: Drug: avacincaptad pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Up to 12 Months

Secondary outcomes (12)

  1. Number of participants with intraocular pressure (IOP) abnormalities and/or AEs

    Number of participants with potentially clinically significant IOP values.

    Measured: 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.

    Measured: Up to 12 months

  3. Number of participants with laboratory value abnormalities and/or AEs

    Number of participants with potentially clinically significant laboratory values.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Baseline and up to 12 months

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

    ADA will be recorded from the serum samples collected.

    Measured: 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.

    Measured: Up to 12 months

  11. PK of ASP3021 in plasma: Concentration

    Concentration will be recorded from the PK plasma samples collected.

    Measured: 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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study start8 Jul 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06970665
Sponsor's protocol ID
3021-CL-3001
Other IDs
jRCT2031250086
Status last verified
Oct 2026
First submitted
6 May 2025
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing avacincaptad pegol in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Astellas Pharma Inc at 11 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06970665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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