Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Sponsor: BlueRock Therapeutics
Summary
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.
Official title: A Phase 1/2a Study of Subretinal Administration of OpCT-001 Photoreceptor Precursor Cells Derived From iPSCs in Patients With Primary Photoreceptor Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2025-03-10
Completion Date
2030-10
Last Updated
2025-12-26
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (3)
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