Nicotinamide + Pyruvate for Open-Angle Glaucoma

Not currently recruiting at 3 trial locations

Overseen By Lisa A. Hark, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Columbia University

Must be taking: Glaucoma medications

Disqualifiers: Cataract, Dementia, Neurological disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 87 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of oral nicotinamide and pyruvate can help maintain eye health in people with open-angle glaucoma. Participants will receive either this combination or a placebo, while continuing their usual glaucoma medications. The goal is to determine if this new treatment improves outcomes compared to not adding anything extra. The trial seeks individuals diagnosed with certain types of glaucoma, such as primary open-angle glaucoma, who have manageable eye pressure.

As a Phase 2, Phase 3 trial, the study measures the treatment's effectiveness in a smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to potentially groundbreaking advancements in glaucoma treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using nicotinamide and pyruvate together can provide short-term benefits for people with glaucoma, particularly in improving vision. However, there is insufficient information about the safety of nicotinamide for treating glaucoma. Some studies suggest that high doses might cause liver problems, but this is not confirmed for everyone.

This trial is in Phase 2/3, indicating that the treatment has already demonstrated some safety and effectiveness in earlier tests. At this stage, the trial aims to confirm safety and assess how well the treatment works for a larger group.

In summary, while results appear promising, the complete safety of nicotinamide and pyruvate for glaucoma remains under study. Participants should consider these factors when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glaucoma?

Researchers are excited about the combination of Nicotinamide and Pyruvate for open-angle glaucoma because it introduces a novel approach to managing the condition. Unlike standard treatments, which typically focus on lowering intraocular pressure through eye drops, laser treatments, or surgery, this combination targets cellular energy pathways. Nicotinamide, a form of vitamin B3, and Pyruvate work together to potentially protect the optic nerve by enhancing cellular metabolism and reducing oxidative stress. This unique mechanism could offer a new way to slow or prevent vision loss in glaucoma patients, making it a promising addition to the current treatment landscape.

What evidence suggests that nicotinamide and pyruvate might be an effective treatment for open-angle glaucoma?

Research has shown that nicotinamide and pyruvate, which participants in this trial may receive, can help improve vision in people with glaucoma. In earlier studies, participants who took this combination noticed better short-term vision. This treatment supports the health of the nerves in the eyes and has shown promise in improving vision when used alongside regular glaucoma medications. These findings suggest that nicotinamide and pyruvate could effectively treat open-angle glaucoma. ^{1 2 3 6 7}

Who Is on the Research Team?

Aakriti G. Shukla, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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

I have been diagnosed with a specific type of glaucoma.

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

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.

IOP at screening or baseline visit ≥ 25 mmHg

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Nicotinamide and Pyruvate
• Placebo

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.

How Is the Trial Designed?

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+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Systemic administration of nicotinamide riboside (NR), a precursor to NAD+, significantly enhances the survival of retinal ganglion cells (RGCs) in both acute and chronic models of RGC damage in mice, indicating its potential as a protective treatment for glaucoma.

NR treatment not only preserved RGC function but also reduced retinal inflammation, suggesting a dual mechanism of action that could be beneficial in managing glaucoma, even when intraocular pressure is controlled.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Treatment with Nicotinamide Riboside Is Protective in Two Mouse Models of Retinal Ganglion Cell Damage. Zhang, X., Zhang, N., Chrenek, MA., et al.[2021]

Nicotinamide (vitamin B3) shows promise as a potential treatment for glaucoma, with studies indicating a strong link between low levels of NAD+ and retinal ganglion cell dysfunction, which is critical in glaucoma.

Research suggests that nicotinamide supplementation may improve retinal ganglion cell function in both animal models and human studies, but further investigation is necessary to establish its efficacy, optimal dosing, and safety for broader use in glaucoma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Glaucoma and age-related macular degeneration are major causes of irreversible blindness, and current treatments only manage symptoms rather than addressing the underlying causes of these neurodegenerative diseases.

The review suggests that low levels of nicotinamide adenine dinucleotide (NAD) may contribute to the disease mechanisms, and that providing external sources of NAD could become a new therapeutic approach for treating these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Benefit of NAD+ Supplementation for Glaucoma and Age-Related Macular Degeneration. Cimaglia, G., Votruba, M., Morgan, JE., et al.[2021]

Vitamin B3 compounds, nicotinamide (NAM) and nicotinamide riboside (NR), are being explored as potential adjuvant therapies for glaucoma, aiming to protect retinal ganglion cells (RGCs) and prevent optic nerve damage.

These compounds serve as precursors to nicotinamide adenine dinucleotide (NAD), which is crucial for cell function and may help reduce RGC vulnerability to stressors like increased intraocular pressure, especially in patients who continue to progress despite adequate IOP control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Nicotinamide and Nicotinamide riboside as an adjunct therapy in the treatment of glaucoma. Goulart Nacácio E Silva, S., Occhiutto, ML., Costa, VP.[2023]

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]

Nicotinamide (NAM) treatment improved retinal vasculature in ocular hypertensive rats, showing significant increases in various vessel parameters, indicating its potential to prevent retinal vascular damage in glaucoma.

In human subjects, NAM treatment resulted in small but significant increases in retinal perfusion density in both glaucoma patients and healthy controls, suggesting a beneficial effect on retinal blood flow.

NCBI (Pubmed)

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. Gustavsson, ST., Enz, TJ., Tribble, JR., et al.[2023]

This study is a randomized controlled trial involving 125 patients with primary open-angle glaucoma (POAG) to evaluate the effectiveness of nicotinamide riboside (NR) in slowing optic nerve degeneration over 24 months.

The primary outcome is the rate of retinal nerve fiber layer (RNFL) thinning, which will provide a more objective measure of neuroprotection compared to traditional visual field tests, potentially allowing for quicker assessment of treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide riboside as a neuroprotective therapy for glaucoma: study protocol for a randomized, double-blind, placebo-control trial. Leung, CKS., Ren, ST., Chan, PPM., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34792559/

A Phase 2 Randomized Clinical Trial A combination of nicotinamide and pyruvate yielded significant short-term improvement in visual function, supporting prior experimental research.

2. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/2786482

Nicotinamide and Pyruvate for Neuroenhancement in ... Oral nicotinamide and pyruvate can result in short-term improvement in visual function in patients with treated, manifest glaucoma.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05695027

Nicotinamide and Pyruvate for Open Angle Glaucoma: A ... 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 ...

4. ophthalmologyglaucoma.org ophthalmologyglaucoma.org/article/S2589-4196(25)00007-9/fulltext

American Glaucoma Society-American Academy of ... Nicotinamide and pyruvate for neuroenhancement in open-angle glaucoma: a phase 2 randomized clinical trial. JAMA Ophthalmol. 2022; 140:11-18.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8603231/

Nicotinamide and Pyruvate for Neuroenhancement in ... Oral nicotinamide and pyruvate can result in short-term improvement in visual function in patients with treated, manifest glaucoma.

6. aao.org aao.org/education/clinical-statement/american-glaucoma-society-american-academy-of-opht

American Glaucoma Society and American ... Supplementation with oral nicotinamide to support metabolism resulted in 93% of eyes in the DBA/2J model not developing glaucoma at the highest tested dose.

7. trialx.com trialx.com/clinical-trials/listings/240998/nicotinamide-and-pyruvate-for-open-angle-glaucoma-a-randomized-clinical-study/

Nicotinamide and Pyruvate for Open Angle Glaucoma 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 ...