OpCT-001 for Retinitis Pigmentosa
(CLARICO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 up to approximately 54 adults with primary photoreceptor (PR) disease. Phase 1 will focus 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.
Are You a Good Fit for This Trial?
This trial is for adults with primary photoreceptor diseases like Usher Syndrome, Retinitis Pigmentosa, and other retinal degenerations. Participants should have a specific type of eye condition without any current treatments that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Participants receive OpCT-001 in a dose-escalation design across 4 cohorts to evaluate safety and tolerability
Phase 2 Treatment
Participants are randomized to receive one of two selected dose levels of OpCT-001 to assess safety and visual function outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OpCT-001
Find a Clinic Near You
Who Is Running the Clinical Trial?
BlueRock Therapeutics
Lead Sponsor