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RecruitingPhase 1/Phase 2

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

AAVantgarde Bio Srl · with AAVantgarde Bio UK Ltd · NCT07161544

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 8–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
75
US sites recruiting
8
Study start
September 29, 2025
Record last updated
September 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AAVB-039

Conditions: Stargardt Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Molecular diagnosis of Stargardt disease due to ABCA4 mutation
  • Willingness to adhere to protocol per informed consent

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

Recruiting US locations

  • Associated Retina Consultants

    Phoenix, AZ 85020

    Site contact: Study Team · hello@doctrials.com

  • Children's Hospital Los Angeles

    Los Angeles, CA 90027

    Site contact: Hillary Schwartz-Gale · hschwartz@chla.usc.edu

  • Retina Vitreous Associates Medical Group

    Los Angeles, CA 90211

    Site contact: Kristina Passoian, Trials Director · Kpassoian@laretina.com

  • University of Florida Health Science Center

    Jacksonville, FL 32209

    Site contact: G. Shabbir Hamdani · Shabbir.hamdani@ufhealth.org

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Suzy Wernimont · 507-538-8119 · Wernimont.Suzanne@mayo.edu

  • Retina Consultants of Texas

    Bellaire, TX 77401

    Site contact: Dr. Kenneth Fan

  • Retina Foundation of the Southwest

    Dallas, TX 75231

    Site contact: Senior Clinical Research Coordinator · jclark@retinafoundation.org

  • University of Utah

    Salt Lake City, UT 84112

    Site contact: Kimberley Wegner Lead Coordinator · Kimberley.wegner@hsc.utah.edu

Study contacts (from the official record)

  • AAVantgarde Clinical Operations Lead · +448000465680 · clinicaltrials@aavantgarde.com
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A Study of AAVB-039 in Participants With Stargardt Disease (STGD1) (NCT07161544) | Bored Studies