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

Plain-language summary

This study examines a treatment called AAVB-039 in people with Stargardt disease caused by an ABCA4 gene mutation. It enrolls participants with a confirmed molecular diagnosis who agree to follow the study requirements. The study is in Phase 1/Phase 2 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Recruiting

Sponsor

AAVantgarde Bio Srl

Intervention

AAVB-039

Start date

9/29/2025

Estimated completion

7/1/2032

Countries

United States, United Kingdom

Related genes

Locations

• Phoenix, United States
• Los Angeles, United States
• Rochester, United States
• Bellaire, United States
• Dallas, United States
• Salt Lake City, United States
• London, United Kingdom
• London, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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