A Study of AAVB-039 for Stargardt Disease

This study is testing a treatment called AAVB-039 for people with Stargardt disease (STGD1). Stargardt disease is an inherited eye condition that causes progressive vision loss. Researchers want to see how safe AAVB-039 is and if people can tolerate it after a single injection into the eye. They will also look for early signs of how well it works. You might be able to join if you are between 8 and 55 years old and have a genetic diagnosis of Stargardt disease due to a specific gene change (ABCA4 mutation). The study plans to enroll about 75 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll about 75 participants. It will evaluate a single treatment of AAVB-039.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-related side effects for up to 60 months (5 years) after receiving AAVB-039.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07161544

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

Recruiting
PHASE1Ages 8–55InterventionalTreatment
AAVantgarde Bio Srl
~75 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:AAVB-039

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To measure the number and severity of treatment related adverse events following treatment with AAVB-039
Measured over 0-60 months
Stargardt Disease
9 sites across 7 states
Texas2
England2
Arizona1
California1
Florida1
Minnesota1
Utah1
AAVantgarde Clinical Operations Lead
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Eligibility criteria

Inclusion

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

Exclusion

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
  • To measure the number and severity of treatment related adverse events following treatment with AAVB-0390-60 months