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A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)

Study acronym: CELESTE
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 9 to 11
    • Eligibility criteria expanded, about 7 words
  2. Study sites: 8 to 9v8
  3. Study sites: 7 to 8v7
  4. Study sites: 6 to 7v6
  5. Study sites: 4 to 6v5
Show 3 earlier versionsHide 3 earlier versions
  1. Site contacts updated at 1 of 4 sitesv4
  2. Study sites: 2 to 4v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Sep 29, 2025
    • Site details revised at 2 of 2 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07161544
Lead Sponsor AAVantgarde Bio Srl
Collaborators: AAVantgarde Bio UK Ltd
Conditions
(from sponsor)		 Stargardt Disease
Related terms Stargardt Disease
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov