A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)

Last updated: May 27, 2026
Sponsor: AAVantgarde Bio Srl
Overall Status: Active - Recruiting

Phase

1/2

Condition

Myopic Macular Degeneration

Treatment

AAVB-039

Clinical Study ID

NCT07161544
039-101
  • Ages 8-55
  • All Genders

Study Summary

The purpose of the 039-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-039 in participants with Stargardt disease secondary to a biallelic mutation of the ABCA4 gene. The study will also assess initial efficacy following AAVB-039 administration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Molecular diagnosis of Stargardt disease due to ABCA4 mutation

  • Willingness to adhere to protocol per informed consent

Exclusion

Exclusion Criteria:

  • Unwillingness to meet the requirements of the study

  • Participation in a clinical study with another Investigation Medicinal Product

  • Previous participation in another gene or cell therapy trial

  • Any condition that would preclude subretinal surgery

  • Complicating ocular and/or systemic diseases

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: AAVB-039
Phase: 1/2
Study Start date:
September 29, 2025
Estimated Completion Date:
July 31, 2032

Connect with a study center

  • Moorfields Eye Hospital NHS Foundation Trust

    London, England EC1V 2PD
    United Kingdom

    Active - Recruiting

  • The Retina Clinic

    London, England W1G 9AX
    United Kingdom

    Active - Recruiting

  • The Retina Clinic

    London 2643743, England 6269131 W1G 9AX
    United Kingdom

    Active - Recruiting

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Retina Vitreous Associates Medical Group

    Los Angeles, California 90211
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Retina Foundation of the Southwest

    Dallas, Texas 75231
    United States

    Active - Recruiting

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