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Geographic AtrophyNCT06779773

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

An observational study of Geographic Atrophy and Macular Degeneration, run by Astellas Pharma Global Development, Inc. at 58 sites in United States.

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

This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Read more about this study

Who is it for?
Any age
Conditions the study is for
Geographic Atrophy, Macular Degeneration
What is being tested?
Avacincaptad pegol (ACP)
Type of treatment
Injection or infusion
How many people
488 participants
Where
58 sitesUnited States
Study dates
22 Jan 2025to 31 Oct 2030
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants from both academic and non-academic sites, urban and rural across the US to ensure a heterogenous population that is representative of the US GA secondary to AMD population and reflective of real-world practice patterns.

Who may be able to join

  • Patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in 1 or both eyes
  • Patient with a decision to treat with intravitreal avacincaptad pegol (ACP) prior to enrollment
  • Patient willingness to complete the patient reported outcome (PRO).

Who cannot join

  • Patients who have any contraindication or are not eligible for treatment with ACP, including the following:
  • Active ocular or peri-ocular infection in either eye
  • Active, suspected intraocular inflammation in either eye
  • Hypersensitive to ACP or to any ingredient in the formulation
  • Patients currently participating in an investigational program with interventions outside of routine clinical practice.
  • Patients who have received ACP in the eye being considered for enrollment. Note: Patients who have received or are receiving ACP in the fellow eye at baseline are eligible to be included in the study.
  • Patients who have received any intravitreal complement inhibitor other than ACP in either eye. Note: Patients who have received an intravitreal complement inhibitor other than ACP in either eye and have completed the 90-day washout period are eligible to be included in the study.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Southeast Retina Center, P.C.

    Augusta, Georgia, 30909

  • Rocky Mountain Lions Eye Institute

    Aurora, Colorado, 80045

  • Advanced Retina Institute

    Bonita Springs, Florida, 34134

  • SightMD

    Brentwood, New York, 11717

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • The Ohio State University

    Columbus, Ohio, 43221

  • University of Miami

    Coral Gables, Florida, 33146

  • Retina of North Texas

    Dallas, Texas, 75243

  • CEI Physicians PSC, LLC dba

    Dayton, Ohio, 45459

  • Eye Associates of North Jersey PA

    Dover, New Jersey, 07801

  • NJ Retina

    Edison, New Jersey, 08820

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Verum Research, LLC

    Eugene, Oregon, 97401

  • The Retina Group of Washington

    Fairfax, Virginia, 22031

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439

  • Coastal Eye Surgeons

    Greenwich, Connecticut, 05830

  • Cumberland Valley Retina Consultants,P.C.

    Hagerstown, Maryland, 21740

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37920

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37923

  • Harvard Eye Associates

    Laguna Hills, California, 92653

  • Colorado Retina Associates, PLLC

    Lakewood, Colorado, 80228

  • NJ Retina

    Lakewood, New Jersey, 08701

  • Retina-Vitreous Surgeons of Central NY

    Liverpool, New York, 13088

  • Piedmont Eye Center, Inc.

    Lynchburg, Virginia, 24502

  • Mississippi Retina Associates

    Madison, Mississippi, 39110

  • NY Retina Ophthalmology PLLC

    Massapequa, New York, 11758

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Mid South Retina Associates

    Memphis, Tennessee, 38119

  • Retina & Vitreous Consultants of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Retina Associates of Utah, P.C.

    Murray, Utah, 84107

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

  • Retina Associates of New York

    New York, New York, 10075

  • University Retina and Macula Associates, P.C.

    Oak Forest, Illinois, 60452

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

  • Brown Family Retina PLLC

    Olive Branch, Mississippi, 38654

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Illinois Eye Center

    Peoria, Illinois, 61615

  • Retinal Consultants of AZ

    Phoenix, Arizona, 85053

  • Retina Consultants of Southern CA

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95825

  • Retina Consultants of Minnesota PLLC

    Saint Louis Park, Minnesota, 55416

  • Salt Lake Retina

    Salt Lake City, Utah, 84120

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retina Associates Of South Texas, Pa

    San Antonio, Texas, 78240

  • Long Island Vitreoretinal Consultants

    Scarsdale, New York, 10583

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255

  • Vitreoretinal Consultants

    Shirley, New York, 11967

  • Deep Blue Retina Clinical Research

    Southaven, Mississippi, 38671

  • Eye Physicians of Pinellas PA dba Eye Institute of West Florida

    Tampa, Florida, 33606

  • NJ Retina

    Toms River, New Jersey, 08755

  • Retina Macula Institute

    Torrance, California, 90503

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587

  • Virginia Retina Center

    Warrenton, Virginia, 20186

  • Retina Specialists of Tampa

    Wesley Chapel, Florida, 33544

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

Other trials in United States

About this study

Official title: A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP/IZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision.

Avacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy.

Read more

This study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor have decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas).

People that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for around 5 years.

Being tested
Avacincaptad pegol (ACP)
Keywords
Avacincaptad Pegol, IZERVAY™, Treatment patterns, Safety, Functional Outcomes
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 pegol (ACP)Drug

    Also called IZERVAY™

    intravitreal injection

Study groups in NCT06779773
Study groupRoleWhat they receive
IzervayPatients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay
Receives: Drug: Avacincaptad pegol (ACP)

What is being measured

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

  1. Number of ACP injections

    The number of ACP injections.

    Measured: Up to 61 Months

  2. Duration of treatment

    The duration of treatment will be calculated as the difference between the date of the last injection and the date of the first injection plus 31 days (as the next injection would be expected at least 30 days after the last one).

    Measured: Up to 61 Months

  3. Annual frequency of ACP injection

    The annual frequency of ACP injections will be calculated as the total number of injections divided by the treatment duration in years.

    Measured: Up to 61 Months

  4. Reasons for discontinuation of treatment with ACP

    The reasons for discontinuation of treatment with ACP will be recorded.

    Measured: Up to 61 Months

  5. Duration of the treatment interval

    The treatment interval is defined as mean number of days between injections, if a study eye receives more than 1 injection.

    Measured: Up to 61 Months

  6. Site characteristics

    Characteristics of interest will be recorded including the type of setting (e.g., public/private facility, rural/urban).

    Measured: Day 1

  7. Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay

    Characteristics of interest will be recorded.

    Measured: Day 1

Secondary outcomes (7)

  1. Number of participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.

    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 a medicinal product whether or not considered related to the medicinal (investigational) product.

    Measured: Up to 61 Months

  2. Number of participants with Serious Adverse Events (SAEs)

    An SAE is defined as an AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or other medically important events.

    Measured: Up to 61 Months

  3. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    TEAE is defined an AE observed after starting administration of the study drug and will continue until 30 days after the last administration or until last study visit, whichever is sooner.

    Measured: Up to 61 Months

  4. Number of participants with Adverse Event of Special Interest (AESI)

    AESIs are defined as the following AEs:

    • Endophthalmitis
    • choroidal neovascularization (CNV)
    • Intraocular inflammation (including retinal vasculitis)
    • Increased intraocular pressure (IOP) ≥ 30 mmHg at 30 minutes post injection deemed clinically significant by the investigator
    • Elevation of IOP post injection requiring surgical/procedural intervention
    • Ischemic optic neuropathy

    Measured: Up to 61 Months

  5. Number of Participants maintaining vision

    Maintaining vision is defined as not losing ≥ 15 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

    Measured: Up to 61 Months

  6. Time to vision loss using various thresholds

    Time to vision loss is defined as the difference between the date when vision loss was reported for the first time and the start date of treatment.

    Measured: Up to 61 Months

  7. Time to thresholds associated with ability to drive

    Time to thresholds associated with the ability to drive will be based on visual acuity data captured as per standard of care.

    Measured: Up to 61 Months

Timeline

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

  1. First posted17 Jan 2025
  2. Study start22 Jan 2025
  3. Primary completion31 Oct 2030 (estimated)
  4. Study completion31 Oct 2030 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06779773
Sponsor's protocol ID
3021-MA-3543
Status last verified
Oct 2026
First submitted
16 Dec 2024
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
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?

An observational study of Geographic Atrophy and Macular Degeneration, run by Astellas Pharma Global Development, Inc. at 58 sites in United States.

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 3 inclusion and 7 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 27 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 58 sites in United States. 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.

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 ACP injections (time frame: Up to 61 Months). The study lists 7 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 NCT06779773.

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 27 Oct 2026.

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