RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-01-22
Study Completion:2030-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06779773

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in 1 or both eyes
  2. * Patient with a decision to treat with intravitreal avacincaptad pegol (ACP) prior to enrollment
  3. * Patient willingness to complete the patient reported outcome (PRO).
  1. * Patients who have any contraindication or are not eligible for treatment with ACP, including the following:
  2. * Active ocular or peri-ocular infection in either eye
  3. * Active, suspected intraocular inflammation in either eye at enrollment/baseline visit
  4. * Hypersensitive to ACP or to any ingredient in the formulation
  5. * Patients currently participating in an investigational program with interventions outside of routine clinical practice.
  6. * 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.
  7. * 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Medical Director
STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.

Study Locations (Sites)

Salt Lake Retina
Salt Lake City, Utah, 84120
United States

Collaborators and Investigators

Sponsor: Astellas Pharma Global Development, Inc.

  • Medical Director, STUDY_DIRECTOR, Astellas Pharma Global Development, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-22
Study Completion Date2030-01-31

Study Record Updates

Study Start Date2025-01-22
Study Completion Date2030-01-31

Terms related to this study

Keywords Provided by Researchers

  • Avacincaptad Pegol
  • IZERVAY™
  • Treatment patterns
  • Safety
  • Functional Outcomes

Additional Relevant MeSH Terms

  • Geographic Atrophy
  • Macular Degeneration