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

Purpose

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.

Conditions

  • Geographic Atrophy
  • Macular Degeneration

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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™

Recruiting Locations

Retinal Consultants of AZ
Phoenix, Arizona 85053

Retina Macula Institute of Arizona
Scottsdale, Arizona 85255

Harvard Eye Associates
Laguna Hills, California 92653

Retina Consultants of Southern CA
Redlands, California 92374

Retinal Consultants Medical Group Inc
Sacramento, California 95825

Retina Macula Institute
Torrance, California 90503

Retina Consultants of Southern Colorado
Colorado Springs, Colorado 80909

Colorado Retina Associates, PLLC
Lakewood, Colorado 80228

Florida Eye Clinic
Altamonte Springs, Florida 32701

Retina Specialists of Tampa
Wesley Chapel, Florida 33544

Southeast Retina Center, P.C.
Augusta, Georgia 30909

Illinois Retina Associates
Oak Park, Illinois 60304

Illinois Eye Center
Peoria, Illinois 61615

Retina Specialists
Towson, Maryland 21204

Retina Associates of Michigan
Grand Blanc, Michigan 48439

Retina Consultants of Minnesota PLLC
Saint Louis Park, Minnesota 55416

Mississippi Retina Associates
Madison, Mississippi 39110

Deep Blue Retina Clinical Research
Southaven, Mississippi 38671

NJ Retina
Edison, New Jersey 08820

NJ Retina
Toms River, New Jersey 08755

SightMD
Brentwood, New York 11717

NY Retina Ophthalmology PLLC
Massapequa, New York 11758

Retina Associates of New York
New York, New York 10075

North Carolina Retina Associates
Cary, North Carolina 27511

North Carolina Retina Associates
Wake Forest, North Carolina 27587

Verum Research, LLC
Eugene, Oregon 97401

Erie Retina Research
Erie, Pennsylvania 16507

Tennessee Retina, PC
Nashville, Tennessee 37203

Retina Research Institute of Texas
Abilene, Texas 79606

Retina Associates of Utah, P.C.
Murray, Utah 84107

Salt Lake Retina
Salt Lake City, Utah 84120

The Retina Group of Washington
Fairfax, Virginia 22031

Piedmont Eye Center, Inc.
Lynchburg, Virginia 24502

Virginia Retina Center
Warrenton, Virginia 20186

Retina & Vitreous Consultants of Wisconsin
Greenfield, Wisconsin 53220

More Details

NCT ID
NCT06779773
Status
Recruiting
Sponsor
Astellas Pharma Global Development, Inc.

Study Contact

Astellas Pharma Global Development, Inc.
800-555-5555
Astellas.registration@astellas.com