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RECRUITINGPhase 1/2NCT07161544

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

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...

Lead sponsor: AAVantgarde Bio Srl•4 U.S. locations•View source on ClinicalTrials.gov

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Contacts

AAVantgarde Clinical Operations Lead

CONTACT

+448000465680 clinicaltrials@aavantgarde.com

Sponsors

Lead Sponsor

AAVantgarde Bio Srl

Collaborators

AAVantgarde Bio UK Ltd

Age

8 - 55 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 9, 2026Terms

Trial snapshot

StatusRECRUITING

PhasePHASE1/PHASE2

Enrollment75

Start dateSep 2025

Last updatedMar 9, 2026

Condition

Stargardt Disease

Locations shown

Retina Vitreous Associates Medical Group

Los Angeles, California

Mayo Clinic

Rochester, Minnesota

Retina Consultants of Texas

Bellaire, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions