Nicotinamide + Pyruvate for Open-Angle Glaucoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Aakriti G. Shukla, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Columbia University

Must be taking: Glaucoma medications

Disqualifiers: Cataract, Dementia, Neurological disease, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop my current medications for this trial?

The trial does not specify that you need to stop taking your current glaucoma medications. In fact, it mentions that standard-of-care intraocular pressure-lowering medications will continue to be used during the study.

What data supports the effectiveness of the drug Nicotinamide and Pyruvate for treating open-angle glaucoma?

Research suggests that nicotinamide, a component of the drug, may help protect eye cells from damage in glaucoma by supporting cell function and reducing stress on the cells. Studies on similar compounds have shown potential benefits in slowing down the progression of glaucoma. ^{1 2 3 4 5}

Is Nicotinamide and Pyruvate safe for humans?

The research suggests that nicotinamide (a form of vitamin B3) is being studied for its potential benefits in treating glaucoma, and it is generally considered safe as it is a vitamin supplement. However, more research is needed to fully understand its safety and appropriate dosing in humans. ^{1 2 3 6 7}

How does the drug Nicotinamide and Pyruvate differ from other treatments for open-angle glaucoma?

Nicotinamide and Pyruvate is unique because it targets the underlying causes of glaucoma, such as mitochondrial dysfunction and oxidative stress, by replenishing nicotinamide adenine dinucleotide (NAD) levels, which are crucial for cell health. Unlike traditional treatments that focus on lowering eye pressure, this drug aims to protect retinal cells directly, potentially slowing disease progression even when eye pressure is controlled. ^{1 2 3 4 7}

Research Team

Aakriti G. Shukla, MD

Principal Investigator

Columbia University

Eligibility Criteria

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.

Inclusion Criteria

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

I have been diagnosed with a specific type of glaucoma.

I am willing to stop taking any supplements for the study period.

Exclusion 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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nicotinamide and pyruvate or placebo for 87 weeks

87 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nicotinamide and Pyruvate (Dietary Supplement)
• Placebo (Other)

Trial Overview 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.

Participant Groups

Group I: Nicotinamide and Pyruvate Experimental Treatment 1 Intervention

The N\&P group will receive nicotinamide and pyruvate for 87 weeks (20 months).

Group II: Placebo Placebo Group 1 Intervention

The placebo group will receive placebo for 87 weeks (20 months).

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Findings from Research

Individuals with primary open-angle glaucoma (POAG) have significantly lower plasma concentrations of nicotinamide compared to age- and sex-matched controls, with reductions of about 30-33%.

These findings suggest that nicotinamide supplementation could be a potential therapeutic strategy for POAG, but further research with larger groups is necessary to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Deficiency in Primary Open-Angle Glaucoma. Kouassi Nzoughet, J., Chao de la Barca, JM., Guehlouz, K., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Benefit of NAD+ Supplementation for Glaucoma and Age-Related Macular Degeneration. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Nicotinamide Deficiency in Primary Open-Angle Glaucoma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The use of Nicotinamide and Nicotinamide riboside as an adjunct therapy in the treatment of glaucoma. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Systemic Treatment with Nicotinamide Riboside Is Protective in Two Mouse Models of Retinal Ganglion Cell Damage. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Nicotinamide riboside as a neuroprotective therapy for glaucoma: study protocol for a randomized, double-blind, placebo-control trial. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

The Role of NAD+ and Nicotinamide (Vitamin B3) in Glaucoma: A Literature Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Nicotinamide Prevents Retinal Vascular Dropout in a Rat Model of Ocular Hypertension and Supports Ocular Blood Supply in Glaucoma Patients. [2023]