RightFit
Not yet recruitingPhase 2

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

NADIR Trial: A Principal Investigator-Initiated, Single-Center, Open-Label, Active-Controlled Phase 2a Study of High-Dose Nicotinamide (Vitamin B3) Supplementation in Adults With Mild to Moderate Primary Open-Angle Glaucoma (POAG)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether nicotinamide, a high-dose vitamin B3 supplement, can slow damage to nerve cells in the retina, the light-sensing layer at the back of the eye. It is for adults ages 40 to 80 with primary open-angle glaucoma who already use eye drops or have had laser treatment. Over 12 months, researchers will compare people taking the supplement plus usual care with people receiving usual care alone.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 to 80, with primary open-angle glaucoma in at least one eye confirmed by an eye doctor.
  • Mild to moderate glaucoma in the study eye, based on a reliable side-vision test.
  • Vision of 20/40 or better in the study eye when wearing glasses or contacts if needed.
  • Eye scans or repeat side-vision tests show glaucoma damage. The nerve layers in the study eye must still be thick enough to measure changes.
  • On stable eye-pressure treatment with drops and/or prior laser treatment for at least 4 months, with no changes planned.
  • Eye pressure of 21 mmHg or less in the study eye at screening.
  • Already receiving ongoing glaucoma care at the University of Chicago Medicine Duchossois Center for Advanced Medicine Eye Clinic.
  • Able and willing to give written consent and follow all study visits and steps.

Who can't join

  • Advanced glaucoma, or normal-tension glaucoma, where eye pressure stays at 21 mmHg or less without pressure-lowering treatment.
  • Other major retina or eye-nerve disease; cloudiness that prevents clear eye scans; or inflammation inside the study eye within the past 3 months.
  • Eye surgery in the past 6 months, except cataract surgery without problems or selective laser trabeculoplasty, a laser treatment for glaucoma.
  • Liver blood tests above the study limits, severely reduced kidney function, or poorly controlled diabetes with an HbA1c above 9%.
  • Use of, or unwillingness to avoid, the listed non-study B3 or NAD+ supplements, Ginkgo biloba, CoQ10, isoniazid, pyrazinamide, carbamazepine, phenobarbital, or primidone.
  • Participation in another study of an experimental drug within 30 days before screening.
  • Pregnant, breastfeeding, or planning to become pregnant during the study.
  • Major memory or thinking problems, inability to follow study steps, or any condition the study doctor believes would make participation unsafe or results hard to interpret.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 40 to 80 years, inclusive * Diagnosis of primary open-angle glaucoma (POAG) in at least one eye, confirmed by a licensed ophthalmologist or optometrist based on characteristic optic nerve head changes and/or visual field defects with an open anterior chamber angle * Mild to moderate glaucoma severity in the study eye: Humphrey Visual Field 24-2 mean deviation (MD) between -2.0 and -12.0 dB on at least one reliable test (fixation losses 33% or less, false positive rate 15% or less) * Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent) in the study eye * Confirmed glaucomatous structural damage on SD-OCT (average GCIPL and/or RNFL below age-adjusted normative mean on device-generated classification) and/or a reproducible visual field defect on Humphrey Visual Field 24-2 consistent with glaucoma, as confirmed by the enrolling glaucoma specialist at screening * Macular GCIPL and peripapillary RNFL above device-specific SD-OCT floor effect in the study eye * Currently receiving stable intraocular pressure-lowering therapy (topical medications and/or prior selective laser trabeculoplasty) for at least 4 months prior to enrollment, with no planned changes to glaucoma therapy at the time of enrollment * Intraocular pressure of 21 mmHg or less on current therapy at the screening visit in the study eye * Established patient receiving ongoing glaucoma care at University of Chicago Medicine Duchossois Center for Advanced Medicine Eye Clinic * Willing and able to provide written informed consent and comply with all study visit schedules and procedures * Study eye selection: when POAG is present bilaterally, the study eye is defined as the eye with more severe disease (worse VF MD) that meets all eligibility criteria; if both eyes are equivalent in severity, the right eye is designated by default Exclusion Criteria: * Advanced glaucoma: visual field MD worse than -12.0 dB in the study eye * Significant retinal disease affecting macular structure or visual field, including advanced age-related macular degeneration, diabetic retinopathy greater than mild non-proliferative, clinically significant diabetic macular edema, major retinal vein occlusion, or non-glaucomatous optic neuropathy * Ocular surgery other than uncomplicated cataract extraction or selective laser trabeculoplasty within the past 6 months * Hepatic dysfunction at baseline: AST or ALT greater than 2 times the upper limit of normal, or total bilirubin greater than 1.5 times the upper limit of normal * Renal dysfunction: eGFR less than 30 mL/min/1.73 m2 * Current use of, or unwillingness to abstain from: nicotinamide, niacinamide, nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), or any other NAD+-precursor supplement not dispensed by the study; high-dose niacin or vitamin B3; Ginkgo biloba; CoQ10; isoniazid; pyrazinamide; carbamazepine; phenobarbital; primidone; or sustained-release niacin or nicotinamide formulations * Poorly controlled diabetes mellitus: HbA1c greater than 9.0% at screening * Normal tension glaucoma with documented intraocular pressure consistently 21 mmHg or less without hypotensive therapy * Participation in another investigational drug trial within 30 days of screening * Pregnancy, lactation, or intent to become pregnant during the study period * Significant cognitive impairment or inability to comply with study requirements * Clinically significant media opacity (corneal, lenticular, or vitreal) sufficient to degrade OCT signal quality below device-minimum thresholds, even if BCVA of 20/40 or better is preserved * Active or recent uveitis or intraocular inflammation in the study eye within the past 3 months * Any condition that, in the investigator's judgment, would preclude safe participation or confound result interpretation

Study sites (1)

IL