NCT06789445RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
A Phase 1/2a Study of Subretinal Administration of OpCT-001 Photoreceptor Precursor Cells Derived From iPSCs in Patients With Primary Photoreceptor Disease
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 17 Jan 2025
- Start date
- 10 Mar 2025
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- BlueRock Therapeutics
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT06789445
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 54
- From 10 Mar 2025 to the primary completion date, 31 Oct 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ocular surgery ≤3 months before Screening
- Previously received a bone marrow or solid organ transplant
Other illness
- Clinically relevant, active ocular inflammation or infection
- 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
Other
- 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
- Monocular vision (ie, no light perception in the fellow eye)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina Foundation of the Southwest Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Southern California /Children's Hospital of Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| University of Miami, Bascom Palmer Eye Institute Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Mid Atlantic Retina/ Wills Eye Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.