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

NCT06970665 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 3021-CL-3001jRCT2031250086
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Geographic Atrophy; Age-Related Macular Degeneration

Keywords

avacincaptad pegol; IZERVAY; ASP3021

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 12 Months

Secondary Outcomes (12)

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

  Up to 12 months

• Number of participants with ophthalmic examination abnormalities and/or AEs

  Up to 12 months

• Number of participants with laboratory value abnormalities and/or AEs

  Up to 12 months

• Number of participants with vital signs abnormalities and/or AEs

  Up to 12 months

• Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs

  Up to 12 months

Study Arms (1)

ASP3021

EXPERIMENTAL

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

Drug: avacincaptad pegol

Interventions

avacincaptad pegol DRUG

intravitreal injection

Also known as: ASP3021, IZERVAY

ASP3021

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (16)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

RECRUITING

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

RECRUITING

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

RECRUITING

Kyoto University Hospital

Kyoto, Kyoto, Japan

RECRUITING

Mie University Hospital

Tsu, Mie-ken, Japan

RECRUITING

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

RECRUITING

University of the Ryukyus hospital

Ginowan-shi, Okinawa, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

RECRUITING

The University of Osaka Hospital

Suita-shi, Osaka, Japan

RECRUITING

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

RECRUITING

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan

RECRUITING

Nihon University Hospital

Chiyoda-ku, Tokyo, Japan

RECRUITING

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

RECRUITING

Toyama University Hospital

Toyama, Toyama, Japan

RECRUITING

University Of Yamanashi Hospital

Chuo-shi, Yamanashi, Japan

RECRUITING

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Associate Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Inc.

CONTACT

+81-3-3244-6500 Japanese only; astellas.registration@astellas.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (16)