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Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Minor Study sites: 10 to 11
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 1 of 1 entry
  2. Minor Enrollment target: 13 to 15v10
  3. Minor Eligibility criteria revisedv9
  4. Minor Site details revised at 1 of 10 sitesv8
  5. Minor Study title expanded, about 1 wordv7
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  1. Minor Site details revised at 2 of 10 sitesv6
  2. Minor Site details revised at 1 of 10 sitesv5
  3. Minor Study sites: 4 to 10v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Minor Start date changed from estimate of Jun 29, 2024 to Jun 11, 2024v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.
Trial Details
NCT Number NCT06467344
Lead Sponsor Ascidian Therapeutics, Inc
Conditions
(from sponsor)
Stargardt Disease, Cone Rod Dystrophy, Juvenile Macular Degeneration, Stargardt Disease 1
Related terms Cone-Rod Dystrophies, Stargardt Disease
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov