Using Nicotinamide and Pyruvate to Support Eye Health in Glaucoma Patients

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

This study is testing if taking nicotinamide and pyruvate can help people with glaucoma keep their vision from getting worse compared to a placebo.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 35 Years to 85 Years
• Sex: All
• Sponsor: Columbia University (Academic / other)
• Locations: 3 sites (Palo Alto, California and 2 other locations)
• Trial ID: NCT05695027 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a combination of oral nicotinamide and pyruvate in maintaining eye health in patients with primary open-angle glaucoma, compared to a placebo. A total of up to 188 participants will be enrolled and randomly assigned to receive either the nutritional supplements or a placebo for 87 weeks, with follow-up extending to 91 weeks. The study will assess the impact of these supplements on visual field progression, which is crucial for monitoring glaucoma's effects on vision. The trial seeks to determine if these over-the-counter supplements can enhance visual field testing performance and slow disease progression.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 35 to 85 with a confirmed diagnosis of primary open-angle glaucoma or related conditions.

Not a fit: Patients with advanced glaucoma or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, non-invasive approach to slowing the progression of glaucoma and preserving vision.

How similar studies have performed: Previous studies have suggested that nutritional supplements like nicotinamide and pyruvate may improve visual field testing performance, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria

1. Willing and able to provide informed consent for participation in the study.
2. Between 35 and 85 years of age.
3. 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.
4. Have a confirmed diagnosis of primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.
5. If there is a prior reliable 24-2, the MD should be better than -20dB.
6. 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.
7. Have best corrected visual acuity better than or equal to 20/40 in the study eye.
8. 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.

Exclusion Criteria

1. Glaucoma or cataract surgery anticipated in the next 18 months.
2. Have a diagnosis of significant cataract or media opacity affecting the visual field test or imaging studies.
3. Have a diagnosis of dementia, Alzheimer's, or other neurological disease.
4. Have an inability to take or intolerance to nicotinamide and/or pyruvate.
5. 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.
6. Prior complicated cataract surgery (e.g., vitrectomy, etc)
7. 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).
8. Retinal pathology that significantly affects visual acuity (worse than 20/40) or visual field.
9. 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).
10. IOP at screening or baseline visit ≥ 25 mmHg.
11. Have a known history of liver disease.
12. Are pregnant or are planning to become pregnant.

Where this trial is running

Palo Alto, California and 2 other locations

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

Study contacts

• Principal investigator: Aakriti G. Shukla, MD — Columbia University
• Study coordinator: Aakriti G. Shukla, MD

Conditions Primary Open Angle Glaucoma; nutritional supplement; nicotinamide; pyruvate