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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 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 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

2026-04-13

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 (4)

University of Miami, Bascom Palmer Eye Institute

Miami, Florida, United States

Mid Atlantic Retina/ Wills Eye

Philadelphia, Pennsylvania, United States

Retina Foundation of the Southwest

Dallas, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States