Status:
RECRUITING
A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)
Lead Sponsor:
AAVantgarde Bio Srl
Collaborating Sponsors:
AAVantgarde Bio UK Ltd
Conditions:
Stargardt Disease
Eligibility:
All Genders
8-55 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
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
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2032
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07161544
Start Date
September 29 2025
End Date
July 1 2032
Last Update
December 12 2025
Active Locations (4)
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1
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
2
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
3
Moorfields Eye Hospital NHS Foundation Trust
London, England, United Kingdom, EC1V 2PD
4
The Retina Clinic
London, England, United Kingdom, W1G 9AX