RecruitingPhase 1Phase 2NCT06789445

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

A Phase 1/2a Study of Subretinal Administration of OpCT-001 Photoreceptor Precursor Cells Derived From iPSCs in Patients With Primary Photoreceptor Disease

Sponsor

BlueRock Therapeutics

Enrollment

54 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Retinitis pigmentosa (RP)Retinal Degeneration Primary Photoreceptor Disease Cone-Rod Dystrophy Rod-Cone Dystrophy Usher Syndrome Inherited Retinal Disease (IRD)Rod-Cone Disease Cone-Rod Disease (C-RD)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called OpCT-001 and a biological treatment called OpCT-001 for people with cone-rod disease (c-rd), cone-rod dystrophy, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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