A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
NCT ID: NCT06789445
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
54 participants
INTERVENTIONAL
2025-03-10
2030-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Dose escalation in Phase 1 will be conducted using a standard 3+3 scheme in which a total of up to 24 legally blind participants (\~3 to 6 per cohort) will receive OpCT-001. Phase 2 is planned to enroll a maximum of 15 participants per cohort in 2 cohorts to evaluate 2 dose levels of OpCT-001 that will be selected based on Phase 1 safety and tolerability data. Phase 2 participants will be randomized 1:1 to either cohort. Phase 2 participants and the investigator/study site personnel outside of the surgical team will be masked to OpCT-001 dose assignments.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 3
OpCT-001 dose level 3 will be administered via subretinal injection.
OpCT-001
Cell therapy product composed of photoreceptor precursor cells derived from human iPSCs.
Cohort 4
OpCT-001 dose level 4 will be administered via subretinal injection.
OpCT-001
Cell therapy product composed of photoreceptor precursor cells derived from human iPSCs.
Cohort 1
OpCT-001 dose level 1 will be administered via subretinal injection.
OpCT-001
Cell therapy product composed of photoreceptor precursor cells derived from human induced pluripotent stem cells (iPSCs).
Cohort 2
OpCT-001 dose level 2 will be administered via subretinal injection.
OpCT-001
Cell therapy product composed of photoreceptor precursor cells derived from human iPSCs.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OpCT-001
Cell therapy product composed of photoreceptor precursor cells derived from human induced pluripotent stem cells (iPSCs).
OpCT-001
Cell therapy product composed of photoreceptor precursor cells derived from human iPSCs.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 1.0. BCVA at Screening for Phase 2: ETDRS letter score 20 and 60.
* Retinal structure examination in the study eye demonstrating regions suitable for cell administration.
Exclusion Criteria
* Glaucoma or other significant optic neuropathy
* Diabetic macular edema or diabetic retinopathy
* Clinically significant cystoid macular edema
* 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)
* Presence of clinically significant anti-OpCT-001 Human Leukocyte Antigen (HLA) antibodies at Screening
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BlueRock Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Patient Engagement
Role: primary
Patient Engagement
Role: primary
Patient Engagement
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OpCT-001-101
Identifier Type: -
Identifier Source: org_study_id