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80 Participants NeededMy employer runs this trial

NPI-001 for Retinitis Pigmentosa

(SLORP Preserve Trial)

NP
Overseen ByNacuity Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Nacuity Pharmaceuticals, Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with retinitis pigmentosa linked to Usher syndrome. Participants must have a certain level of vision, be able to follow study instructions, and agree to use contraception if needed. They should also be on stable medication doses for other conditions.

Inclusion Criteria

EZ width ≥ 500 microns, which includes the fovea in each eye at Visit 1
All edges of the EZ area in both my eyes can be seen during screening.
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)
See 4 more

Exclusion Criteria

I have an eye condition that causes vision loss or trouble focusing.
History of known sensitivity to N-acetylcysteine or similar thiol compounds or any ingredients of NPI-001
History of hypersensitivity to any medication or food resulting in systemic symptoms
See 16 more

What Are the Treatments Tested in This Trial?

Interventions

  • NPI-001

Trial Overview

The study tests whether NPI-001 can slow down vision loss in people with Usher syndrome-related retinitis pigmentosa compared to a placebo. Participants take either NPI-001 or placebo twice daily for 24 months and attend regular clinic visits.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NPI-001Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nacuity Pharmaceuticals, Inc.

Lead Sponsor

Trials
3
Recruited
90+

Foundation Fighting Blindness

Collaborator

Trials
17
Recruited
22,400+

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