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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Primary Open Angle Glaucoma

In brief

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).

Key facts

Study ID

NCT05695027

Run by

Columbia University

People needed

250

Starts

2023-03-14

Expected to finish

2028-01-01

Last updated by the study team

2026-07-15

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)
• 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.

Where it is running

• Stanford University Department of Ophthalmology — Palo Alto, California, United States
• ColumbiaDoctors Ophthalmology - 880 Third Avenue — New York, New York, United States
• Columbia University Irving Medical Center - 622 W 168th St — New York, New York, United States

Full record on ClinicalTrials.gov

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