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CLARICO Study: OpCT-001 for Primary Photoreceptor Disease

This study, called CLARICO, is testing a new cell therapy called OpCT-001 for adults with primary photoreceptor disease, including conditions like Retinitis Pigmentosa (RP) and Usher Syndrome. OpCT-001 is made of special photoreceptor precursor cells grown from human stem cells. The main goal of the study is to see how safe OpCT-001 is and if you experience any side effects over 52 weeks. Later parts of the study will also look at how it affects your vision. You may be able to join if you are an adult with a confirmed genetic diagnosis of primary photoreceptor disease and meet specific vision requirements. The study is currently recruiting about 54 participants.

Study design
This is a Phase 1/2a study with two parts. Phase 1 is open-label, meaning everyone knows they are receiving OpCT-001, and involves increasing doses in small groups. Phase 2 will involve up to 30 participants, where some will be masked to the dose level they receive.
What's involved
You would receive OpCT-001 and be monitored for side effects through weekly visits for 52 weeks after treatment.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety and side effects for 52 weeks after receiving OpCT-001.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06789445

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BlueRock Therapeutics
~54 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:OpCT-001

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) through the Week 52 visit
Measured over From OpCT-001 administration through the Week 52 visit

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

Explore related trials

Cone-Rod DystrophiesHereditary nephropathyPrimary Photoreceptor DiseaseRetinitis PigmentosaRod-Cone DystrophyUsher Syndrome

Where it's being run

5 sites across 5 states
California1
Florida1
Pennsylvania1
Texas1
Wisconsin1

Who to contact

Patient Engagement
[email protected]
1-877-380-3931
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) through the Week 52 visitFrom OpCT-001 administration through the Week 52 visit