A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
Eligibility
Primary outcome measure(s)
- Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) through the Week 52 visit — From OpCT-001 administration through the Week 52 visit
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Southern California /Children's Hospital of Los Angeles | Los Angeles | California | Recruiting |
| University of Miami, Bascom Palmer Eye Institute | Miami | Florida | Recruiting |
| Mid Atlantic Retina/ Wills Eye | Philadelphia | Pennsylvania | Recruiting |
| Retina Foundation of the Southwest | Dallas | Texas | Recruiting |
| University of Wisconsin | Madison | Wisconsin | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06789445 on ClinicalTrials.gov ↗ ← All trials in the USA