Nacuity Pharmaceuticals, Inc.
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.
Inclusion Criteria: 1. Able to comprehend and willing to sign an informed consent form (OCF) and adhere to the study protocol. 2. Diagnosed with RP associated with Usher syndrome. 3. EZ width ≥ 500 microns, which includes the fovea in each eye at Visit 1. 4. All edges of the EZ area in both eyes can be visualized at Visit 1 (Screening). 5. Have at least 20 detectable points on the MAIA grid in at least one eye at the Screening and Baseline visits (same eye for both visits). 6. On stable dose of medications associated with other conditions for at least one month. 7. Willing to use contraceptio…
Oral placebo tablet
Oral n-acetyl cysteine amide tablet (250mg)
Arctuva estimate
Verify or correct the compensation shown for this listing.