A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Avacincaptad pegol (ACP).
- Who it may be relevant to
- Registry conditions: Geographic Atrophy, Macular Degeneration. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 have 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 around 5 years.
Interventions
- Drug Avacincaptad pegol (ACP)
intravitreal injection
Primary outcome measures
- Number of ACP injections [Time frame: Up to 61 Months]
- Duration of treatment [Time frame: Up to 61 Months]
- Annual frequency of ACP injection [Time frame: Up to 61 Months]
- Reasons for discontinuation of treatment with ACP [Time frame: Up to 61 Months]
- Duration of the treatment interval [Time frame: Up to 61 Months]
- Site characteristics [Time frame: Day 1]
- Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay [Time frame: Day 1]
Secondary outcome measures (7)
- Number of participants with Adverse Events (AEs) [Time frame: Up to 61 Months]
- Number of participants with Serious Adverse Events (SAEs) [Time frame: Up to 61 Months]
- Number of participants with Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 61 Months]
- Number of participants with Adverse Event of Special Interest (AESI) [Time frame: Up to 61 Months]
- Number of Participants maintaining vision [Time frame: Up to 61 Months]
- Time to vision loss using various thresholds [Time frame: Up to 61 Months]
- Time to thresholds associated with ability to drive [Time frame: Up to 61 Months]
Eligibility criteria
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
- 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 eye being considered for enrollment. Note: Patients who have received or are receiving ACP in the fellow eye at baseline 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 65 centers
- Phoenix Retina Clinical Trials, LLC — Phoenix
- Retinal Consultants of AZ — Phoenix
- Retina Macula Institute of Arizona — Scottsdale
- The Retina Partners — Encino
- Harvard Eye Associates — Laguna Hills
- University of California Irvine Medical Center — Orange
- Retina Consultants of Southern CA — Redlands
- Retinal Consultants Medical Group Inc — Sacramento
- … and 57 more centers
Identifiers
NCT: NCT06779773 · 3021-MA-3543