drugset / Trial / NCT07710196
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Phase 3
Not yet recruiting
80 enrolled
Nacuity Pharmaceuticals, Inc.
Foundation Fighting Blindness · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this clinical trial is to learn if NPI-001 works to prevent progression of retinitis pigmentosa in adults diagnosed with Usher syndrome. It will also provide information about the safety of NPI-001. The main questions it aims to answer are: Does NPI-001 slow down the loss of photoreceptors? What medical problems do participants have when taking NPI-001? Researchers will compare NPI-001 to a placebo (a look-alike substance that contains no drug) to see if NPI-001 works to preserve vision. Participants will: Take NPI-001 or a placebo twice a day, every day for 24 months and visit the clinic 9 times for checkups and tests.
Timeline
- Start
- 2026-08
- Primary completion
- 2029-02
- Completion
- 2029-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | N-Acetylcysteine Amide | Unknown | — | Oral |