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

Last updated: April 14, 2025
Sponsor: Astellas Pharma Global Development, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Geographic Atrophy

Macular Degeneration

Treatment

Avacincaptad pegol (ACP)

Clinical Study ID

NCT06779773
3021-MA-3543
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 toenrollment

  • Patient willingness to complete the patient reported outcome (PRO).

Exclusion

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/baselinevisit

  • Hypersensitive to ACP or to any ingredient in the formulation

  • Patients currently participating in an investigational program with interventionsoutside of routine clinical practice.

  • Patients who have received ACP in the study eye. Note: Patients who have received orare 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 ineither eye. Note: Patients who have received an intravitreal complement inhibitorother than ACP in either eye and have completed the 90-day washout period areeligible to be included in the study.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Avacincaptad pegol (ACP)
Phase:
Study Start date:
January 22, 2025
Estimated Completion Date:
January 31, 2030

Connect with a study center

  • Retinal Consultants of AZ

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Retina Consultants of Southern CA

    Redlands, California 92374
    United States

    Active - Recruiting

  • Florida Eye Clinic

    Altamonte Springs, Florida 32701
    United States

    Active - Recruiting

  • Retina Specialists of Tampa

    Wesley Chapel, Florida 33544
    United States

    Active - Recruiting

  • Illinois Eye Center

    Peoria, Illinois 61615
    United States

    Active - Recruiting

  • SightMD

    Brentwood, New York 11717
    United States

    Active - Recruiting

  • Retina Associates of New York

    New York, New York 10075
    United States

    Active - Recruiting

  • Salt Lake Retina

    Salt Lake City, Utah 84120
    United States

    Active - Recruiting

  • Virginia Retina Center

    Warrenton, Virginia 20186
    United States

    Active - Recruiting

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