Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis
← catalyst calendarNCT05203939 · readout ≤ 224 d
Sponsored by Ocugen (industry) · OCGN — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
22actual
Sites
7
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-24 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-01-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Retinitis Pigmentosa
- Leber Congenital Amaurosis
Interventions
- Drug: OCU400 Low Dose
- Drug: OCU400 Med Dose
- Drug: OCU400 High Dose
- Drug: OCU400 Second Eye Dosing
Primary outcomes
what the primary-completion date above is the date OFStudy Drug-related adverse events (SDAE)
measured 1 year
Treatment-Emergent adverse events (TEAEs)
measured 1 year
Serious adverse events (SAEs)
measured 1 year
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