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RECRUITING
NCT06789445
PHASE1/PHASE2

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

Sponsor: BlueRock Therapeutics

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

OpCT-001

Cell therapy product composed of photoreceptor precursor cells derived from human induced pluripotent stem cells (iPSCs).

BIOLOGICAL

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