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
| Arm | Description | Assigned Intervention |
|---|---|---|
| Izervay | Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay |
|
Recruiting Locations
Phoenix, Arizona 85050
Phoenix, Arizona 85053
Scottsdale, Arizona 85255
Encino, California 91436
Laguna Hills, California 92653
Redlands, California 92374
Sacramento, California 95825
Torrance, California 90503
Aurora, Colorado 80045
Colorado Springs, Colorado 80909
Lakewood, Colorado 80228
Greenwich, Connecticut 05830
Bonita Springs, Florida 34134
Coral Gables, Florida 33146
Palm Beach Gardens, Florida 33410
Tampa, Florida 33606
Wesley Chapel, Florida 33544
Augusta, Georgia 30909
Oak Forest, Illinois 60452
Oak Park, Illinois 60304
Peoria, Illinois 61615
West Des Moines, Iowa 50266
Hagerstown, Maryland 21740
Towson, Maryland 21204
Grand Blanc, Michigan 48439
Saint Louis Park, Minnesota 55416
Madison, Mississippi 39110
Olive Branch, Mississippi 38654
Southaven, Mississippi 38671
Reno, Nevada 89502
Dover, New Jersey 07801
Edison, New Jersey 08820
Lakewood, New Jersey 08701
Little Silver, New Jersey 07739
Toms River, New Jersey 08755
Brentwood, New York 11717
Liverpool, New York 13088
Scarsdale, New York 10583
Shirley, New York 11967
Wake Forest, North Carolina 27587
Columbus, Ohio 43221
Dayton, Ohio 45459
Eugene, Oregon 97401
Erie, Pennsylvania 16507
Knoxville, Tennessee 37920
Knoxville, Tennessee 37923
Memphis, Tennessee 38119
Nashville, Tennessee 37203
Abilene, Texas 79606
Bellaire, Texas 77401
Dallas, Texas 75243
McAllen, Texas 78503
San Antonio, Texas 78240
San Antonio, Texas 78240
Murray, Utah 84107
Salt Lake City, Utah 84120
Fairfax, Virginia 22031
Lynchburg, Virginia 24502
Warrenton, Virginia 20186
More Details
- Status
- Recruiting
- Sponsor
- Astellas Pharma Global Development, Inc.
Study Contact
Astellas Pharma Global Development, Inc.800-555-5555
Astellas.registration@astellas.com