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A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)
An Open-label, Multicenter, Two Part, Ascending Dose Followed by a Controlled Trial to Assess the Safety and Efficacy of a Subretinal Administration of AAVB-039 in Participants With Stargardt Disease (STGD1) (CELESTE)
Who can join
Ages 8 to 55 · All sexes
Full eligibility 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
About the study
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.
What is being tested
- AAVB-039 (biological)
Sponsor: AAVantgarde Bio Srl · Participants: 75 · Started: Sep 29, 2025
Contact the study team
- AAVantgarde Clinical Operations Lead · Phone: +448000465680
Official record on ClinicalTrials.gov — NCT07161544
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.