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

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.

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 has 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 up to 3 years or up to 5 years, depending on when they start the study.

Study Overview

• Status: Recruiting
• Conditions: Macular Degeneration; Geographic Atrophy
• Intervention / Treatment: Drug: Avacincaptad pegol (ACP)

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Astellas Pharma Global Development, Inc.; Phone Number: 800-555-5555; Email: Astellas.registration@astellas.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Recruiting
      • Retinal Consultants of AZ
    • Phoenix, Arizona, United States, 85050
      • Recruiting
      • Phoenix Retina Clinical Trials, LLC
    • Scottsdale, Arizona, United States, 85255
      • Recruiting
      • Retina Macula Institute of Arizona
  • California
    • Encino, California, United States, 91436
      • Recruiting
      • The Retina Partners
    • Laguna Hills, California, United States, 92653
      • Recruiting
      • Harvard Eye Associates
    • Orange, California, United States, 92868
      • Recruiting
      • University of California Irvine Medical Center
    • Redlands, California, United States, 92374
      • Recruiting
      • Retina Consultants of Southern CA
    • Sacramento, California, United States, 95825
      • Recruiting
      • Retinal Consultants Medical Group Inc
    • Torrance, California, United States, 90503
      • Recruiting
      • Retina Macula Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Rocky Mountain Lions Eye Institute
    • Colorado Springs, Colorado, United States, 80909
      • Recruiting
      • Retina Consultants of Southern Colorado
    • Lakewood, Colorado, United States, 80228
      • Recruiting
      • Colorado Retina Associates, PLLC
  • Connecticut
    • Greenwich, Connecticut, United States, 05830
      • Recruiting
      • Coastal Eye Surgeons
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Withdrawn
      • Florida Eye Clinic
    • Bonita Springs, Florida, United States, 34134
      • Recruiting
      • Advanced Retina Institute
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • University of Miami
    • Palm Beach Gardens, Florida, United States, 33410
      • Recruiting
      • Retina Care Specialists
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Eye Physicians of Pinellas PA dba Eye Institute of West Florida
    • Wesley Chapel, Florida, United States, 33544
      • Recruiting
      • Retina Specialists of Tampa
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Recruiting
      • Southeast Retina Center, P.C.
  • Illinois
    • Oak Forest, Illinois, United States, 60452
      • Recruiting
      • University Retina and Macula Associates, P.C.
    • Oak Park, Illinois, United States, 60304
      • Recruiting
      • Illinois Retina Associates
    • Peoria, Illinois, United States, 61615
      • Recruiting
      • Illinois Eye Center
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Recruiting
      • Wolfe Eye Clinic
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Recruiting
      • Cumberland Valley Retina Consultants,P.C.
    • Towson, Maryland, United States, 21204
      • Withdrawn
      • Retina Specialists
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Recruiting
      • Retina Associates of Michigan
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Recruiting
      • Retina Consultants of Minnesota PLLC
  • Mississippi
    • Madison, Mississippi, United States, 39110
      • Recruiting
      • Mississippi Retina Associates
    • Olive Branch, Mississippi, United States, 38654
      • Recruiting
      • Brown Family Retina PLLC
    • Southaven, Mississippi, United States, 38671
      • Recruiting
      • Deep Blue Retina Clinical Research
  • Nevada
    • Reno, Nevada, United States, 89502
      • Recruiting
      • Sierra Eye Associates
  • New Jersey
    • Dover, New Jersey, United States, 07801
      • Recruiting
      • Eye Associates of North Jersey PA
    • Edison, New Jersey, United States, 08820
      • Recruiting
      • NJ Retina
    • Lakewood, New Jersey, United States, 08701
      • Recruiting
      • NJ Retina
    • Little Silver, New Jersey, United States, 07739
      • Withdrawn
      • Monmouth Retina Consultants
    • Toms River, New Jersey, United States, 08755
      • Recruiting
      • NJ Retina
  • New York
    • Brentwood, New York, United States, 11717
      • Recruiting
      • SightMD
    • Liverpool, New York, United States, 13088
      • Recruiting
      • Retina-Vitreous Surgeons of Central NY
    • Massapequa, New York, United States, 11758
      • Active, not recruiting
      • NY Retina Ophthalmology PLLC
    • New York, New York, United States, 10075
      • Active, not recruiting
      • Retina Associates of New York
    • Scarsdale, New York, United States, 10583
      • Recruiting
      • Long Island Vitreoretinal Consultants
    • Shirley, New York, United States, 11967
      • Recruiting
      • Vitreoretinal Consultants
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Withdrawn
      • North Carolina Retina Associates
    • Wake Forest, North Carolina, United States, 27587
      • Recruiting
      • North Carolina Retina Associates
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Recruiting
      • The Ohio State University
    • Dayton, Ohio, United States, 45459
      • Recruiting
      • CEI Physicians PSC, LLC dba
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Verum Research, LLC
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Recruiting
      • Erie Retina Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • Southeastern Retina Associates, P.C.
    • Knoxville, Tennessee, United States, 37923
      • Recruiting
      • Southeastern Retina Associates, P.C.
    • Memphis, Tennessee, United States, 38119
      • Recruiting
      • Mid South Retina Associates
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Retina, PC
  • Texas
    • Abilene, Texas, United States, 79606
      • Recruiting
      • Retina Research Institute of Texas
    • Bellaire, Texas, United States, 77401
      • Withdrawn
      • Retina & Vitreous of Texas
    • Dallas, Texas, United States, 75243
      • Recruiting
      • Retina of North Texas
    • McAllen, Texas, United States, 78503
      • Recruiting
      • Valley Retina Institute
    • San Antonio, Texas, United States, 78240
      • Recruiting
      • Medical Center Ophthalmology Associates
    • San Antonio, Texas, United States, 78240
      • Recruiting
      • Retina Associates Of South Texas, Pa
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Retina Associates of Utah, P.C.
    • Salt Lake City, Utah, United States, 84120
      • Recruiting
      • Salt Lake Retina
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • The Retina Group of Washington
    • Lynchburg, Virginia, United States, 24502
      • Recruiting
      • Piedmont Eye Center, Inc.
    • Warrenton, Virginia, United States, 20186
      • Recruiting
      • Virginia Retina Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Active, not recruiting
      • Retina & Vitreous Consultants of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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 at enrollment/baseline visit
  • 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 study eye. Note: Patients who have received or are receiving ACP in the fellow eye 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Izervay; Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay	Drug: Avacincaptad pegol (ACP); intravitreal injection; Other Names: IZERVAY™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ACP injections	The number of ACP injections.	Up to 61 Months
Dose of ACP injection	The dose of each ACP injection.	Up to 61 Months
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).	Up to 61 Months
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.	Up to 61 Months
Reasons for discontinuation of treatment with ACP	The reasons for discontinuation of treatment with ACP will be recorded.	Up to 61 Months
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.	Up to 61 Months
Site characteristics	Characteristics of interest will be recorded including the type of setting (e.g., public/private facility, rural/urban).	Day 1
Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay	Characteristics of interest will be recorded.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 61 Months
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.	Up to 61 Months
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.	Up to 61 Months
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	Up to 61 Months
Number of Participants maintaining vision	Maintaining vision is defined as not losing ≥ 15 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart.	Up to 61 Months
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.	Up to 61 Months
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.	Up to 61 Months
Participant's reading speed	Reading speed will be captured as per standard of care and in the method determined by the investigator.	Up to 61 Months

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.
• Investigators: Study Director: Medical Director, Astellas Pharma Global Development, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Functional Outcomes; Treatment patterns; Avacincaptad Pegol; IZERVAY™
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: 3021-MA-3543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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/.