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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: BlueRock Therapeutics • ClinicalTrials.gov ID: NCT06789445

Registry updated: 2026-10-15
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Description

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.

Interventions

  • OpCT-001 (Biological)
    Cell therapy product composed of photoreceptor precursor cells derived from human induced pluripotent stem cells (iPSCs).
  • OpCT-001 (Biological)
    Cell therapy product composed of photoreceptor precursor cells derived from human iPSCs.

Eligibility criteria

Key Inclusion Criteria: * Confirmed genetic diagnosis of primary photoreceptor (PR) disease * Best corrected visual acuity (BCVA) in the study eye at Screening for Phase 1: Logmarithm of the minimum angle of resolution (LogMAR) 3.9 to LogMAR 1.3. BCVA at Screening for Phase 2: ETDRS letter score between 20 to 60, inclusive. * Retinal structure examination in the study eye demonstrating regions suitable for cell administration. Key Exclusion Criteria: * Clinically relevant, active ocular inflammation or infection * Glaucoma or other significant optic neuropathy * Diabetic macular edema or diabetic retinopathy * Clinically significant cystoid macular edema * In phakic participants: Spherical equivalent refractive error of greater than 8.00 diopters myopia * Ocular surgery ≤3 months before Screening * Monocular vision (ie, no light perception in the fellow eye) * Currently active malignancy, or history of malignancy within 5 years before OpCT-001 administration. Exception: Basal cell carcinoma that has been definitively treated. * Any current and active infection (bacterial/viral/fungal) that could put the participant at risk from immunosuppression * History of any cell therapy, gene therapy, or retinal implant at any time * Previously received a bone marrow or solid organ transplant

Conditions

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) Cone-Rod Dystrophy

Locations

  • University of Southern California /Children's Hospital of Los Angeles — Los Angeles, California, United States
  • University of Miami, Bascom Palmer Eye Institute — Miami, Florida, United States
  • Mid Atlantic Retina/ Wills Eye — Philadelphia, Pennsylvania, United States
  • Retina Foundation of the Southwest — Dallas, Texas, United States
  • University of Wisconsin — Madison, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record