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

• Status: Recruiting
• Trial end date: 2028-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria

Participants are eligible for study participation if they meet each of the following inclusion criteria.

1. Willing and able to provide informed consent for participation in the study.

2. Between 40 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 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 10-2, the MD should be better than -15dB.

6. Able to perform reliable visual field testing with 24-2 SITA-Standard SAP (defined as false positive rates <15%, false negative rates <30%) at the most recent office visit.

7. Have a 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.

9. Willing to discontinue taking any vitamin/mineral or herbal supplement for the duration of the study.

Exclusion Criteria

Participants are not eligible for study participation if they meet any of the following 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 MIGS surgery 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 VF and macular 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.