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Primary Open Angle GlaucomaPhase 2/3NCT05695027

Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study

A Phase 2/3 study testing Dietary supplements - Nicotinamide and Pyruvate in people with Primary Open Angle Glaucoma, run by Columbia University at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to determine if a combination of oral nicotinamide and pyruvate (N\&P) can maintain eye health as compared to placebo while standard-of-care intraocular pressure-lowering glaucoma medications are used to treat glaucoma. Read more about this study

Who is it for?
Ages 35 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Primary Open Angle Glaucoma
What is being tested?
Dietary supplements - Nicotinamide and Pyruvate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
3 sitesUnited States
Study dates
14 Mar 2023to Jan 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide informed consent for participation in the study.
  • Between 35 and 85 years of age.
  • Only one eligible eye per patient will be enrolled. If both eyes qualify, study eye will be elected based on the following characteristics (in order of most to least important): 1) disc hemorrhage, 2) higher intraocular pressure (IOP), 3) without previous filtering surgery, 4) better visual acuity. If both eyes meet these four criteria equally, then the study eye will be determined by random assignment.
  • Have a confirmed diagnosis of primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.
  • If there is a prior reliable 24-2, the MD should be better than -20dB.
  • Able to perform reliable visual field testing with 24-2 Swedish Interactive Threshold Algorithm (SITA)-Standard SAP (defined as false positive rates <15%, false negative rates <30%) at the most recent office visit.
  • Have best corrected visual acuity better than or equal to 20/40 in the study eye.
  • Have an IOP (treated or untreated) ≥ 14 mmHg and within 24 months of the baseline visit and one instance of historical IOP ≥ 16 mmHg by patient report or chart.

Who cannot join

  • Glaucoma or cataract surgery anticipated in the next 18 months.
  • Have a diagnosis of significant cataract or media opacity affecting the visual field test or imaging studies.
  • Have a diagnosis of dementia, Alzheimer's, or other neurological disease.
  • Have an inability to take or intolerance to nicotinamide and/or pyruvate.
  • Have undergone incisional glaucoma surgery (trabeculectomy, glaucoma drainage implant, or Xen Gel Stent) within the last 12 months. Phacoemulsification ± canalicular micro-invasive glaucoma surgery (MIGS) is acceptable if performed ≥ 4 months prior to study entry.
  • Prior complicated cataract surgery (e.g., vitrectomy, etc)
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  • Have a functioning trabeculectomy, glaucoma drainage implant, or Xen Gel Stent (defined as being on 0-1 glaucoma medications). If these surgeries have failed and the patient is on ≥ 2 classes of glaucoma medication and meets all other entry criteria, he/she is eligible).
  • Retinal pathology that significantly affects visual acuity (worse than 20/40) or visual field.
  • Refractive disorders and disorders other than glaucoma known to affect the visual field (VF) and macular optical coherence tomography (OCT) imaging (e.g., epiretinal membrane, cystoid macular edema, pathologic myopia, cylinder > 3 diopters, prior history of pars plana vitrectomy with internal limiting membrane peel).
  • IOP at screening or baseline visit ≥ 25 mmHg.
  • Have a known history of liver disease.
  • Are pregnant or are planning to become pregnant.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • ColumbiaDoctors Ophthalmology - 880 Third Avenue

    New York, New York, 10022

  • Columbia University Irving Medical Center - 622 W 168th St

    New York, New York, 10032

  • Stanford University Department of Ophthalmology

    Palo Alto, California, 94303

Other trials in United States

About this study

The objective of this study is to determine if a combination of oral nicotinamide and pyruvate (N\&P) can maintain eye health as compared to placebo while standard-of-care intraocular pressure-lowering glaucoma medications are used to treat glaucoma.

A total of up to 188 participants will be enrolled and randomized 1:1 to receive N\&P or placebo for 87 weeks (20 months). Participants will be followed for a total of 91 weeks (21 months).

Read the detailed description

Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing or standard automated perimetry (SAP). The natural course of glaucoma includes a decline in visual function that matches optic nerve structural changes over time.

Both in clinical practice and in clinical trials, individuals undergo visual field testing at regular intervals in order to define whether progressive changes have occurred as well as the rapidity of change. Visual field results are highly variable within and between sessions, partly due to its subjective nature, which ultimately depends upon the test reliability, individuals' level of experience with the test, variability due to disease severity, and, importantly, the level of individual attentiveness during the test. Therefore, numerous attempts have been made to try to optimize individuals' performance during the test. Some of the approaches reported to date are listening to classical music mitigating background noise and use of nutritional supplements.

Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. The investigators are doing this research study to find out if taking nutritional supplements (vitamin B3 and pyruvate) available over- the-counter can help slow the rate of glaucomatous visual field progression compared to placebo.

Being tested
Dietary supplements - Nicotinamide and Pyruvate, Placebo
Keywords
nutritional supplement, nicotinamide, pyruvate
Medical subject headings
Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary supplements - Nicotinamide and PyruvateDrug

    Nutritional supplements

  • PlaceboDrug

    Placebo

Study groups in NCT05695027
Study groupRoleWhat they receive
Nicotinamide and PyruvateExperimentalThe N\&P group will receive nicotinamide and pyruvate for 87 weeks (20 months).
Receives: Drug: Dietary supplements - Nicotinamide and Pyruvate
PlaceboPlacebo comparatorThe placebo group will receive placebo for 87 weeks (20 months).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in visual field results based on pointwise and global metrics

    The primary outcome in this study are changes in visual field results based on pointwise and global metrics between intervention and placebo groups.

    Measured: 87 weeks

  2. Change in retinal nerve fiber and ganglion cell layer thickness

    The primary outcome in this study are changes in retinal nerve fiber and ganglion cell layer thickness as assessed by optical coherence tomography testing between intervention and placebo groups.

    Measured: 87 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start14 Mar 2023
  3. Primary completionAug 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 Randomization
Masking
Single blind
Who is masked
Participant
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695027
Sponsor's protocol ID
AAAU0211
Status last verified
Jul 2026
First submitted
22 Nov 2022
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liebmann JM, Cioffi GA. Nicking Glaucoma with Nicotinamide? N Engl J Med. 2017 May 25;376(21):2079-2081. doi: 10.1056/NEJMcibr1702486. No abstract available.

    PubMed 28538117

  • De Moraes CG, John SWM, Williams PA, Blumberg DM, Cioffi GA, Liebmann JM. Nicotinamide and Pyruvate for Neuroenhancement in Open-Angle Glaucoma: A Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jan 1;140(1):11-18. doi: 10.1001/jamaophthalmol.2021.4576.

    PubMed 34792559

  • Williams PA, Harder JM, Foxworth NE, Cardozo BH, Cochran KE, John SWM. Nicotinamide and WLDS Act Together to Prevent Neurodegeneration in Glaucoma. Front Neurosci. 2017 Apr 25;11:232. doi: 10.3389/fnins.2017.00232. eCollection 2017.

    PubMed 28487632

  • Williams PA, Harder JM, Foxworth NE, Cochran KE, Philip VM, Porciatti V, Smithies O, John SW. Vitamin B3 modulates mitochondrial vulnerability and prevents glaucoma in aged mice. Science. 2017 Feb 17;355(6326):756-760. doi: 10.1126/science.aal0092.

    PubMed 28209901

  • Shukla AG, Cioffi GA, Liebmann JM. Drug-Induced Liver Injury During a Glaucoma Neuroprotection Clinical Trial. J Glaucoma. 2024 Aug 1;33(8):e58-e59. doi: 10.1097/IJG.0000000000002394. Epub 2024 Mar 28.

    PubMed 38536128

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dietary supplements - Nicotinamide and Pyruvate in people with Primary Open Angle Glaucoma, run by Columbia University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in visual field results based on pointwise and global metrics (time frame: 87 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695027, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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