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Dietary Supplement
Nicotinamide + Pyruvate for Open-Angle Glaucoma
Phase 2 & 3
Recruiting
Led By Aakriti G. Shukla, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 87 weeks
Summary
This trial studies if N&P can help keep eyes healthy when treating glaucoma with standard meds.
Who is the study for?
Adults aged 40-85 with primary open-angle, pseudoexfoliative, or pigmentary glaucoma can join this study. They must be able to consent, have one qualifying eye with specific characteristics if both are eligible, and perform reliable visual field tests. Participants should not be on certain supplements or have had recent incisional glaucoma surgery.
What is being tested?
The trial is testing whether oral nicotinamide and pyruvate supplements can help maintain eye health in glaucoma patients compared to a placebo. All participants will continue their usual glaucoma medications during the 21-month study period.
What are the potential side effects?
Potential side effects of nicotinamide and pyruvate may include mild gastrointestinal issues like nausea or upset stomach. Since these are dietary supplements, severe side effects are less common but could involve liver problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 87 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~87 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in retinal nerve fiber and ganglion cell layer thickness
Change in visual field results based on pointwise and global metrics
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotinamide and PyruvateExperimental Treatment1 Intervention
The N\&P group will receive nicotinamide and pyruvate for 87 weeks (20 months).
Group II: PlaceboPlacebo Group1 Intervention
The placebo group will receive placebo for 87 weeks (20 months).
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,002 Total Patients Enrolled
7 Trials studying Glaucoma
13,223 Patients Enrolled for Glaucoma
Aakriti G. Shukla, MDPrincipal InvestigatorColumbia University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had glaucoma surgery in the last year.I have been diagnosed with dementia, Alzheimer's, or another neurological disease.I have been diagnosed with a significant cataract affecting my vision.I expect to have eye surgery for glaucoma or cataracts soon.I cannot tolerate or take nicotinamide or pyruvate.I had complications from previous cataract surgery.I have a working glaucoma surgery device.I have an eye condition that greatly affects my vision.I have vision issues not related to glaucoma that affect my visual field and OCT imaging.I have a history of liver disease.I have been diagnosed with a specific type of glaucoma.I am willing to stop taking any supplements for the study period.I am between 40 and 85 years old.My eye pressure is 14 mmHg or higher and was once 16 mmHg or more.I am between 40 and 85 years old.If you have had a previous reliable test for your vision (called a 10-2 test), your eye doctor (ophthalmologist) should determine that your vision is better than -15 decibels (dB).
Research Study Groups:
This trial has the following groups:- Group 1: Nicotinamide and Pyruvate
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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