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

Launched by COLUMBIA UNIVERSITY · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of two oral medications, nicotinamide and pyruvate, can help protect eye health in people with primary open-angle glaucoma. The goal is to see if this combination works better than a placebo (a treatment that doesn't contain the actual medication) while participants continue using their regular glaucoma eye drops to lower eye pressure. The trial will enroll up to 188 participants, and each person will be assigned to either receive the nicotinamide and pyruvate or the placebo for about 20 months.

To be eligible for the study, participants need to be between 35 and 85 years old and have a confirmed diagnosis of primary open-angle glaucoma or related conditions. They should also have one eye that meets certain criteria related to eye health. Participants can expect to attend regular check-ups for about 21 months to monitor their eye health and the effects of the treatment. It’s important to note that individuals who are pregnant, have certain eye surgeries planned, or have significant health issues may not qualify for this study.

Gender

ALL

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.