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A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)

Study acronym: CLARICO
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Eligibility criteria expanded, about 14 words
    • Study description revised
    • Site details revised at 2 of 5 sites
  2. Site contacts updated at 2 of 5 sites
    • Collaborators expanded, about 1 word
    v8
  3. Study sites: 4 to 5v7
  4. Study sites: 3 to 4
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 7 words
    v6
  5. Site contacts updated at 3 of 3 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 2 to 3v4 Show 4 more changesShow less
    • Interventions: OpCT-001 (Biological) to OpCT-001 (Biological), OpCT-001 (Biological)
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 5 words
  2. Study sites: 1 to 2v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Aug 2029 to Oct 2029
    • Study completion date: Aug 2030 to Oct 2030
    • Start date changed from estimate of Feb 2025 to Mar 10, 2025
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study OpCT-001-101 is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in approximately 54 adults with primary photoreceptor (PR) disease. Phase 1 focuses on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups.
Trial Details
NCT Number NCT06789445
Lead Sponsor BlueRock Therapeutics
Collaborators: Bayer
Conditions
(from sponsor)		 Primary Photoreceptor Disease, Retinitis Pigmentosa (RP), Usher Syndrome, Inherited Retinal Disease (IRD), Rod-Cone Dystrophy, Rod-Cone Disease, Retinal Degeneration, Cone-Rod Disease (C-RD) +1 more
Related terms Cone-Rod Dystrophies, Retinal Degeneration, Retinitis Pigmentosa, Usher Syndromes
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov