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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 is a Phase 1 study that was terminated before completion, run by Neurophth Therapeutics. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05820152
The ClinicalTrials.gov registry entry for NCT05820152 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurophth Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NFS-02 Injection is the first listed.
NCT05820152 reports 0 study locations.
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.
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