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NCT07681778 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD)
A Phase 1 study, sponsored by Opus Genetics.
- Not yet
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT07681778: Clinical Trial Phase 1 study, sponsored by Opus Genetics.
NCT07681778 is a Phase 1 study that has not yet begun recruiting, run by Opus Genetics. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07681778, a Phase 1 study, has not yet begun recruiting, sponsored by Opus Genetics.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is an early-stage clinical trial (Phase 1b/2a) testing a gene therapy called OPGx-RDH12 for people with Leber Congenital Amaurosis (LCA) caused by mutations in the RDH12 gene, a rare genetic eye disease that leads to severe vision loss. The treatment is delivered as a one-time injection (300 µL) into the retina (subretinal space) of the worse-seeing eye, using a method similar to approved gene therapies like Luxturna. The study is designed to evaluate safety and effectiveness at two dose levels (1E11 and 3E11 viral genomes per eye) in small groups of 5 participants. Each group begins cautiously with 2 adults (age ≥18), treated at least one month apart, followed by FDA review before allowing adolescents (ages 12-17) to participate. An independent monitoring committee (IDMC) oversees safety throughout. After 3 adolescents are treated and followed for 3 months, the committee reviews all data to decide whether to move to a higher dose. However, if the lower dose (1E11 vg/eye) shows strong effectiveness in the first group, the study may expand by treating more adolescents at that same dose instead of increasing it further.
Interventions
- DRUG OPGx-RDH12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2034-07 |
| Phase | Phase 1 |
What is known before NCT07681778 opens enrollment
NCT07681778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which OPGx-RDH12 is the first listed.
NCT07681778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07681778 about?
NCT07681778 is a clinical study titled "Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD)". This study is an early-stage clinical trial (Phase 1b/2a) testing a gene therapy called OPGx-RDH12 for people with Leber Congenital Amaurosis (LCA) caused by mutations in the RDH12 gene, a rare genetic eye disease that leads to severe vision loss. The treatment is delivered as a one-time injection (...
What is the current status of trial NCT07681778?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2026-09-01. Estimated completion is 2034-07.
What interventions are being tested in trial NCT07681778?
The interventions under investigation include: OPGx-RDH12 (DRUG).
Who is sponsoring clinical trial NCT07681778?
This trial is sponsored by Opus Genetics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07681778's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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