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 5308655, Arizona 5551752 85050
Phoenix 5308655, Arizona 5551752 85053
Scottsdale 5313457, Arizona 5551752 85255
Encino 5346649, California 5332921 91436
Laguna Hills 5364306, California 5332921 92653
Redlands 5386754, California 5332921 92374
Sacramento 5389489, California 5332921 95825
Torrance 5403022, California 5332921 90503
Aurora 5412347, Colorado 5417618 80045
Colorado Springs 5417598, Colorado 5417618 80909
Lakewood 5427946, Colorado 5417618 80228
Altamonte Springs 4145941, Florida 4155751 32701
Bonita Springs 4148533, Florida 4155751 34134
Coral Gables 4151871, Florida 4155751 33146
Palm Beach Gardens 4167519, Florida 4155751 33410
Tampa 4174757, Florida 4155751 33606
Wesley Chapel 4177727, Florida 4155751 33544
Augusta 4180531, Georgia 4197000 30909
Oak Forest 4904286, Illinois 4896861 60452
Oak Park 4904381, Illinois 4896861 60304
Peoria 4905687, Illinois 4896861 61615
West Des Moines 4881346, Iowa 4862182 50266
Hagerstown 4357141, Maryland 4361885 21740
Towson 4371582, Maryland 4361885 21204
Grand Blanc 4994320, Michigan 5001836 48439
Saint Louis Park 5045021, Minnesota 5037779 55416
Madison 4434663, Mississippi 4436296 39110
Southaven 4446675, Mississippi 4436296 38671
Dover 5097315, New Jersey 5101760 07801
Edison 5097529, New Jersey 5101760 08820
Lakewood 5100280, New Jersey 5101760 08701
Little Silver 5100559, New Jersey 5101760 07739
Toms River 4504476, New Jersey 5101760 08755
Brentwood 5110077, New York 5128638 11717
Liverpool 5124925, New York 5128638 13088
Massapequa 5126183, New York 5128638 11758
Scarsdale 5136433, New York 5128638 10583
Shirley 5138022, New York 5128638 11967
Cary 4459467, North Carolina 4482348 27511
Wake Forest 4497290, North Carolina 4482348 27587
Columbus 4509177, Ohio 5165418 43221
Dayton 4509884, Ohio 5165418 45459
Eugene 5725846, Oregon 5744337 97401
Erie 5188843, Pennsylvania 6254927 16507
Knoxville 4634946, Tennessee 4662168 37920
Knoxville 4634946, Tennessee 4662168 37923
Memphis 4641239, Tennessee 4662168 38119
Nashville 4644585, Tennessee 4662168 37203
Abilene 4669635, Texas 4736286 79606
Dallas 4684888, Texas 4736286 75243
Houston 4699066, Texas 4736286 77025
McAllen 4709796, Texas 4736286 78503
San Antonio 4726206, Texas 4736286 78240
Murray 5778755, Utah 5549030 84107
Salt Lake City 5780993, Utah 5549030 84120
Fairfax 4758023, Virginia 6254928 22031
Lynchburg 4771075, Virginia 6254928 24502
Warrenton 4792255, Virginia 6254928 20186
Greenfield 5255068, Wisconsin 5279468 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