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

Study acronym: NADIR
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2029 → Dec 31, 2029
See other at-risk trials from University of Chicago

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Sep 30, 2029 to Dec 31, 2029
    • Study completion pushed from Oct 31, 2029 to Feb 27, 2030
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description shortened, about 6 words
  2. Minor Eligibility criteria expanded, about 54 words
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07808333
Lead Sponsor University of Chicago
Conditions
(from sponsor)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Related terms Glaucoma, Open-Angle
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov