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Safety and Tolerability of Subretinally Injected OPGx-BEST1 in Patients With Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB)

Study acronym: BIRD-1
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Study sites: 4 to 5
    • Eligibility criteria expanded, about 30 words
  2. Site contacts updated at 1 of 4 sitesv6
  3. Study sites: 2 to 4v5
  4. Study sites: 1 to 2v4
  5. Start date changed from estimate of Sep 2025 to Sep 25, 2025v3
  6. Site contact updated
    • Collaborators shortened, about 5 words
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to learn if drug OPGx-BEST1 works to treat BVMD and ARB Bestrophinopathy. It will also learn about the safety of drug OPGx-BEST1. The main questions it aims to answer are: Evaluate the safety and tolerability of drug OPGx-BEST1 in one eye (the treatment eye), for 5 years post-injection, in participants with BVMD or ARB. A second question it aims to answer is identification of the most appropriate dose strength of OPGx-BEST1 for clinical development. Evaluate the efficacy of single injection of OPGx-BEST1 in one eye for 5 years post-injection. What medical problems do participants have when taking drug OPGx-BEST1?
Trial Details
NCT Number NCT07185256
Lead Sponsor Opus Genetics, Inc
Conditions
(from sponsor)		 ARB, BVMD, Autosomal-Dominant Bestrophinopathy, Best Vitelliform Macular Dystrophy
Related terms Bestrophinopathy, Vitelliform Macular Dystrophy
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov