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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - 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 waiting period after previous treatment are eligible to be included in the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Avacincaptad pegol (ACP)

intravitreal injection

Locations (20)

Phoenix Retina Clinical Trials, LLC
Phoenix, Arizona, United States
Retinal Consultants of AZ
Phoenix, Arizona, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States
The Retina Partners
Encino, California, United States
Harvard Eye Associates
Laguna Hills, California, United States
Retina Consultants of Southern CA
Redlands, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
Retina Macula Institute
Torrance, California, United States
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
Colorado Retina Associates, PLLC
Lakewood, Colorado, United States
Coastal Eye Surgeons
Greenwich, Connecticut, United States
Florida Eye Clinic
Altamonte Springs, Florida, United States
Advanced Retina Institute
Bonita Springs, Florida, United States
University of Miami
Coral Gables, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Eye Physicians of Pinellas PA dba Eye Institute of West Florida
Tampa, Florida, United States
Retina Specialists of Tampa
Wesley Chapel, Florida, United States
Southeast Retina Center, P.C.
Augusta, Georgia, United States
University Retina and Macula Associates, P.C.
Oak Forest, Illinois, United States