MedTrace Logo

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

NCT06789445 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • 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

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.

Sponsors & Collaborators

  • BlueRock Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2029-10-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789445 on ClinicalTrials.gov