Vitamin B3 may shield retinal nerves in glaucoma

NCT ID NCT07808333

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether high-dose nicotinamide, a form of vitamin B3, can slow the loss of retinal nerve cells in adults with mild to moderate open-angle glaucoma. Participants already on standard glaucoma treatment will be randomly assigned to also take nicotinamide tablets or to continue standard care alone. Over 12 months, researchers will use eye scans to compare the rate of retinal thinning between the two groups. The goal is to see if this supplement offers extra protection for the optic nerve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-dose nicotinamide (vitamin B3) tablets taken by mouth
What this could lead to
If it works, adding vitamin B3 to standard glaucoma care could slow vision loss and point toward a new way to protect retinal nerve cells.
What could go wrong
This is an early, small phase 2a trial. High-dose nicotinamide may not slow nerve thinning, and side effects from taking 3 grams daily are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Exclusion Criteria: * Advanced glaucoma: visual field MD worse than -12.0 dB or BCVA worse than 20/40 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: NAD+/nicotinamide supplements, 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Chicago Medicine Duchossois Center for Advanced Medicine

    Chicago, Illinois, 60637, United States

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