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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)
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.
Age
8 - 55 years
Sex
ALL
Healthy Volunteers
No
Retina Vitreous Associates Medical Group
Los Angeles, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Moorfields Eye Hospital NHS Foundation Trust
London, England, United Kingdom
The Retina Clinic
London, England, United Kingdom
Start Date
September 29, 2025
Primary Completion Date
July 1, 2032
Completion Date
July 1, 2032
Last Updated
March 9, 2026
75
ESTIMATED participants
AAVB-039
BIOLOGICAL
Lead Sponsor
AAVantgarde Bio Srl
Collaborators
NCT07439887
NCT04545736
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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 ConditionsNCT06942572