Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA-Associated Inherited Retinal Degeneration (LCA-IRD)
← catalyst calendarNCT07681778 · readout ≤ 2,326 d
Sponsored by Opus Genetics, Inc (industry) · IRD — their whole pipeline →.
Phase
Phase 1/2
Status
Not yet recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
10estimated
Sites
3
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 | 2026-09-01 | estimated | When the study began enrolling |
| Primary completion | Dec 2032 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2034 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Leber Congenital Amaurosis
- Leber Congenital Amaurosis (LCA)
Intervention
- Drug: OPGx-RDH12
Primary outcomes
what the primary-completion date above is the date OFNumber of dose-limiting toxicity (DLT) events at the proposed doses
measured 5 Years
Number and severity of procedure-related AEs
measured 5 Years
Number and severity of AEs related to OPGx-RDH12
measured 5 Years
Qualitative assessment of cross-sectional spectral-domain optical coherence tomography (SD-OCT), fundus photography, and fundus autofluorescence (FAF) images
measured 5 Years
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