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NCT05820152 · ClinicalTrials.gov registry record · Phase 1
Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND1 Mutations
A Phase 1 study, sponsored by Neurophth Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT05820152: Clinical Trial Phase 1 study, sponsored by Neurophth Therapeutics.
NCT05820152 is a Phase 1 study that was terminated before completion, run by Neurophth Therapeutics. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05820152, a Phase 1 study, was terminated before completion, sponsored by Neurophth Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The objective of this clinical study is to evaluate the safety, tolerability and preliminary efficacy of NFS-02 in the treatment of LHON caused by mitochondrial ND1 gene mutation. This study will enroll subjects aged ≥ 18 years old and ≤ 75 years old to receive a single unilateral intravitreal (IVT) injection of NFS-02 to evaluate its safety, tolerability and preliminary efficacy. The clinical manifestations of all subjects are to be reduced visual acuity caused by LHON associated with ND1 mutation, with laboratory test showing G3460A mutation (a CLIA-certified laboratory) and reduced visual acuity lasted for \> 6 months and \< 10 years.
Primary Outcome
Incidence of adverse events (AEs) within 52 weeks of NFS-02 intravitreal injection at different doses
Interventions
- DRUG NFS-02 Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2024-06-24 |
| Phase | Phase 1 |
Why NCT05820152 stopped before completion
NCT05820152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which NFS-02 Injection is the first listed.
NCT05820152 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05820152 about?
NCT05820152 is a clinical study titled "Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND1 Mutations". The objective of this clinical study is to evaluate the safety, tolerability and preliminary efficacy of NFS-02 in the treatment of LHON caused by mitochondrial ND1 gene mutation. This study will enroll subjects aged ≥ 18 years old and ≤ 75 years old to receive a single unilateral intravitreal (IVT)...
What is the current status of trial NCT05820152?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2023-08-15. Estimated completion is 2024-06-24.
What interventions are being tested in trial NCT05820152?
The interventions under investigation include: NFS-02 Injection (DRUG).
Who is sponsoring clinical trial NCT05820152?
This trial is sponsored by Neurophth Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05820152's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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