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RecruitingPhase 1/Phase 2

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

BlueRock Therapeutics · with Bayer · NCT06789445

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
54
US sites recruiting
5
Study start
March 10, 2025
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: OpCT-001; OpCT-001

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Southern California /Children's Hospital of Los Angeles

    Los Angeles, CA 90007

    Site contact: Patient Engagement · 877-380-3931 · clinicaltrials@bluerocktx.com

  • University of Miami, Bascom Palmer Eye Institute

    Miami, FL 33136

    Site contact: Patient Engagement · 877-380-3931 · clinicaltrials@bluerocktx.com

  • Mid Atlantic Retina/ Wills Eye

    Philadelphia, PA 19107

    Site contact: Patient Engagement · 877-380-3931 · clinicaltrials@bluerocktx.com

  • Retina Foundation of the Southwest

    Dallas, TX 75231

    Site contact: Patient Engagement · 877-380-3931 · clinicaltrials@bluerocktx.com

  • University of Wisconsin

    Madison, WI 53705

    Site contact: Patient Engagement · 877-380-3931 · clinicaltrials@bluerocktx.com

Study contacts (from the official record)

  • Patient Engagement · 1-877-380-3931 · clinicaltrials@bluerocktx.com
All phase 1 studies in California →
A Study to Investigate the Safety of OpCT-001 in Adults Who Have… (NCT06789445) | Bored Studies