drugset / Trial / NCT07808333

Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)

NCT07808333 ↗

Phase 2 Not yet recruiting 96 enrolled University of Chicago
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn whether a high-dose vitamin B3 supplement called nicotinamide can protect retinal nerve cells in adults with primary open-angle glaucoma (POAG) who are already receiving standard glaucoma eye drops or laser treatment. The main question it aims to answer is: Does adding nicotinamide to standard glaucoma therapy slow the rate of thinning of the inner retinal nerve cell layer (measured by a non-invasive eye scan) compared to standard therapy alone over 12 months? Participants will be randomly assigned to one of two groups. Participants in the treatment group will take nicotinamide tablets by mouth, starting at a lower dose (1.5 grams per day) for the first 6 weeks and increasing to the full dose (3.0 grams per day) for the remainder of the 12-month study. Participants in the control group will continue their standard glaucoma care without the supplement. Researchers will compare retinal imaging measurements between the two groups to see whether nicotinamide reduces the rate of retinal nerve cell thinning over time.

Timeline

Start
2027-06-01
Primary completion
2029-09-30
Completion
2029-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotinamide Other / unclassified 1500 mg Oral

Indications