A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)
Recruiting now · Phase 1/Phase 2
Conditions studied: Stargardt Disease
In brief
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.
Key facts
- Study ID
- NCT07161544
- Run by
- AAVantgarde Bio Srl
- People needed
- 75
- Starts
- 2025-09-29
- Expected to finish
- 2032-07-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 8 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Molecular diagnosis of Stargardt disease due to ABCA4 mutation
- Willingness to adhere to protocol per informed consent
You may not qualify if…
- 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
Where it is running
- Associated Retina Consultants — Phoenix, Arizona, United States (enrolling)
- Retina Vitreous Associates Medical Group — Los Angeles, California, United States (enrolling)
- University of Florida Health Science Center — Jacksonville, Florida, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Retina Consultants of Texas — Bellaire, Texas, United States (enrolling)
- Retina Foundation of the Southwest — Dallas, Texas, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
- Moorfields Eye Hospital NHS Foundation Trust — London, England, United Kingdom (enrolling)
- The Retina Clinic — London, England, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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