NCT07161544RecruitingPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- 29 Sept 2025
- Primary completion date
- Jul 2032
- Lead sponsor
- AAVantgarde Bio Srl
- NCT number
- NCT07161544
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 75
- From 29 Sept 2025 to the primary completion date, Jul 2032
- 11 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in another gene or cell therapy trial
Other illness
- Any condition that would preclude subretinal surgery
- Complicating ocular and/or systemic diseases
Other
- Unwillingness to meet the requirements of the study
- Participation in a clinical study with another Investigation Medicinal Product
Who the study is looking for
- Molecular diagnosis of Stargardt disease due to ABCA4 mutation
- Willingness to adhere to protocol per informed consent
Age in the registry: 8 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Retina Clinic Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Moorfields Eye Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Retina Foundation of the Southwest Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Florida Health Science Center Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Retina Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Associated Retina Consultants Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.