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
1 other identifier
observational
1,000
1 country
65
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
Longer than P75 for all trials
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedStudy Start
First participant enrolled
January 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2030
April 9, 2026
April 1, 2026
5 years
December 16, 2024
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (8)
Number of participants with Adverse Events (AEs)
Up to 61 Months
Number of participants with Serious Adverse Events (SAEs)
Up to 61 Months
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Up to 61 Months
Number of participants with Adverse Event of Special Interest (AESI)
Up to 61 Months
Number of Participants maintaining vision
Up to 61 Months
- +3 more secondary outcomes
Study Arms (1)
Izervay
Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Phoenix Retina Clinical Trials, LLC
Phoenix, Arizona, 85050, United States
Retinal Consultants of AZ
Phoenix, Arizona, 85053, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255, United States
The Retina Partners
Encino, California, 91436, United States
Harvard Eye Associates
Laguna Hills, California, 92653, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Retina Consultants of Southern CA
Redlands, California, 92374, United States
Retinal Consultants Medical Group Inc
Sacramento, California, 95825, United States
Retina Macula Institute
Torrance, California, 90503, United States
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909, United States
Colorado Retina Associates, PLLC
Lakewood, Colorado, 80228, United States
Coastal Eye Surgeons
Greenwich, Connecticut, 05830, United States
Florida Eye Clinic
Altamonte Springs, Florida, 32701, United States
Advanced Retina Institute
Bonita Springs, Florida, 34134, United States
University of Miami
Coral Gables, Florida, 33146, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Eye Physicians of Pinellas PA dba Eye Institute of West Florida
Tampa, Florida, 33606, United States
Retina Specialists of Tampa
Wesley Chapel, Florida, 33544, United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909, United States
University Retina and Macula Associates, P.C.
Oak Forest, Illinois, 60452, United States
Illinois Retina Associates
Oak Park, Illinois, 60304, United States
Illinois Eye Center
Peoria, Illinois, 61615, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Cumberland Valley Retina Consultants,P.C.
Hagerstown, Maryland, 21740, United States
Retina Specialists
Towson, Maryland, 21204, United States
Retina Associates of Michigan
Grand Blanc, Michigan, 48439, United States
Retina Consultants of Minnesota PLLC
Saint Louis Park, Minnesota, 55416, United States
Mississippi Retina Associates
Madison, Mississippi, 39110, United States
Brown Family Retina PLLC
Olive Branch, Mississippi, 38654, United States
Deep Blue Retina Clinical Research
Southaven, Mississippi, 38671, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Eye Associates of North Jersey PA
Dover, New Jersey, 07801, United States
NJ Retina
Edison, New Jersey, 08820, United States
NJ Retina
Lakewood, New Jersey, 08701, United States
Monmouth Retina Consultants
Little Silver, New Jersey, 07739, United States
NJ Retina
Toms River, New Jersey, 08755, United States
SightMD
Brentwood, New York, 11717, United States
Retina-Vitreous Surgeons of Central NY
Liverpool, New York, 13088, United States
NY Retina Ophthalmology PLLC
Massapequa, New York, 11758, United States
Retina Associates of New York
New York, New York, 10075, United States
Long Island Vitreoretinal Consultants
Scarsdale, New York, 10583, United States
Vitreoretinal Consultants
Shirley, New York, 11967, United States
North Carolina Retina Associates
Cary, North Carolina, 27511, United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587, United States
The Ohio State University
Columbus, Ohio, 43221, United States
CEI Physicians PSC, LLC dba
Dayton, Ohio, 45459, United States
Verum Research, LLC
Eugene, Oregon, 97401, United States
Erie Retina Research
Erie, Pennsylvania, 16507, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, 37920, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, 37923, United States
Mid South Retina Associates
Memphis, Tennessee, 38119, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Retina & Vitreous of Texas
Bellaire, Texas, 77401, United States
Retina of North Texas
Dallas, Texas, 75243, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retina Associates Of South Texas, Pa
San Antonio, Texas, 78240, United States
Retina Associates of Utah, P.C.
Murray, Utah, 84107, United States
Salt Lake Retina
Salt Lake City, Utah, 84120, United States
The Retina Group of Washington
Fairfax, Virginia, 22031, United States
Piedmont Eye Center, Inc.
Lynchburg, Virginia, 24502, United States
Virginia Retina Center
Warrenton, Virginia, 20186, United States
Retina & Vitreous Consultants of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2024
First Posted
January 17, 2025
Study Start
January 22, 2025
Primary Completion (Estimated)
January 31, 2030
Study Completion (Estimated)
January 31, 2030
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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/.