A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome

Part of paid clinical trials in Dallas, Texas.

Sponsor
Nacuity Pharmaceuticals, Inc.
Study ID
NCT07710196
Phase
PHASE3
Status
Recruiting
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Conditions

  • Retinitis Pigmentosa (RP)
  • Usher Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Oral placebo tablet
  • NPI-001 — DRUG
    Oral n-acetyl cysteine amide tablet (250mg)

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Oct 31, 2026
Status verified
Oct 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Oral Placebo Tablet (BID)
  • Experimental: NPI-001
    Oral N-Acetyl Cysteine Amide Tablet (250 mg BID)

Primary Outcome Measure

Ellipsoid Zone Area [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Foundation of the SouthwestDallasTexas75231
Jadan Crow
[email protected]
214-363-3911

Find similar trials in Dallas, TX

By research site
Retina Foundation of the Southwest· Dallas, TX

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