Actively Recruiting
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Led by BlueRock Therapeutics · Updated on 2026-04-13
54
Participants Needed
4
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed genetic diagnosis of primary photoreceptor disease
- Best corrected visual acuity in the study eye at Screening for Phase 1: LogMAR 3.9 to LogMAR 1.3
- Best corrected visual acuity in the study eye at Screening for Phase 2: ETDRS letter score between 20 to 60, inclusive
- Retinal structure in the study eye suitable for cell administration
You will not qualify if you...
- Active ocular inflammation or infection
- Glaucoma or significant optic neuropathy
- Diabetic macular edema or diabetic retinopathy
- Clinically significant cystoid macular edema
- Phakic participants with myopia greater than 8.00 diopters spherical equivalent
- Eye surgery within 3 months before Screening
- Monocular vision with no light perception in the fellow eye
- Current active malignancy or history within 5 years, except treated basal cell carcinoma
- Current active infection that could risk immunosuppression
- History of any cell therapy, gene therapy, or retinal implant
- Previous bone marrow or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Actively Recruiting
2
Mid Atlantic Retina/ Wills Eye
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
3
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Actively Recruiting
4
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
P
Patient Engagement
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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