A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Recruiting
Phase 1
Phase 2
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 54 (estimated)
- Sponsor
- BlueRock Therapeutics · Industry
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About 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 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 m…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* 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 be…
Contacts