Nicotinamide + Pyruvate for Open-Angle Glaucoma
Palo Alto (17 mi)Overseen byAakriti G. Shukla, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Columbia University
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).
What safety data exists for Nicotinamide and Pyruvate treatment in glaucoma?The provided research does not directly address the safety data for the combination of Nicotinamide and Pyruvate in treating glaucoma. However, it discusses the potential therapeutic benefits and mechanisms of Nicotinamide (a form of vitamin B3) and its role in managing glaucoma. The studies highlight the need for more research into the efficacy, appropriate dosing, and potential side effects of Nicotinamide supplementation before it can be widely recommended for glaucoma treatment. No specific safety data for the combination with Pyruvate is mentioned.12567
Is Nicotinamide and Pyruvate a promising treatment for open-angle glaucoma?Yes, Nicotinamide and Pyruvate show promise as a treatment for open-angle glaucoma. Research suggests that Nicotinamide, a form of vitamin B3, can help protect eye cells and improve their function. It may also help maintain eye health by supporting blood supply and reducing stress on the cells. This makes it a potential new way to treat glaucoma beyond just lowering eye pressure.12367
What data supports the idea that Nicotinamide + Pyruvate for Open-Angle Glaucoma is an effective treatment?The available research shows that using nicotinamide, a form of vitamin B3, as part of a treatment for open-angle glaucoma may help protect the cells in the eye that are important for vision. Studies suggest that nicotinamide can help maintain the health of these cells even when the usual treatment of lowering eye pressure is not enough. This is because nicotinamide helps with important cell functions and reduces stress on the cells. While the research is promising, more studies are needed to confirm its effectiveness in humans.12346
Do I need to stop my current medications to join the trial?The trial does not specify if you need to stop your current medications. However, it mentions that standard-of-care glaucoma medications will be used, so you may continue those.
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.Treatment Details
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.
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).
Find a clinic near you
Research locations nearbySelect from list below to view details:
Columbia University Irving Medical Center - 635 W 165th StNew York, NY
Columbia University Irving Medical Center - 622 W 168th StNew York, NY
ColumbiaDoctors Ophthalmology - 880 Third AvenueNew York, NY
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
References
Nicotinamide Deficiency in Primary Open-Angle Glaucoma. [2019]To investigate the plasma concentration of nicotinamide in primary open-angle glaucoma (POAG).
Potential Therapeutic Benefit of NAD+ Supplementation for Glaucoma and Age-Related Macular Degeneration. [2021]Glaucoma and age-related macular degeneration are leading causes of irreversible blindness worldwide with significant health and societal burdens. To date, no clinical cures are available and treatments target only the manageable symptoms and risk factors (but do not remediate the underlying pathology of the disease). Both diseases are neurodegenerative in their pathology of the retina and as such many of the events that trigger cell dysfunction, degeneration, and eventual loss are due to mitochondrial dysfunction, inflammation, and oxidative stress. Here, we critically review how a decreased bioavailability of nicotinamide adenine dinucleotide (NAD; a crucial metabolite in healthy and disease states) may underpin many of these aberrant mechanisms. We propose how exogenous sources of NAD may become a therapeutic standard for the treatment of these conditions.
Systemic Treatment with Nicotinamide Riboside Is Protective in Two Mouse Models of Retinal Ganglion Cell Damage. [2021]Glaucoma etiology often includes retinal ganglion cell (RGC) death associated with elevated intraocular pressure (IOP). However, even when IOP is managed well, disease can progress. It is thus important to develop therapeutic approaches that directly protect RGCs in an IOP-independent manner. Compromised nicotinamide adenine dinucleotide (NAD+) metabolism occurs in neurodegenerative diseases, including models of glaucoma. Here we report testing the protective effects of prophylactically systemically administered nicotinamide riboside (NR), a NAD+ precursor, in a mouse model of acute RGC damage (optic nerve crush (ONC)), and in a chronic model of RGC degeneration (ocular hypertension induced by intracameral injection of microbeads). For both models, treatment enhanced RGC survival, assessed by counting cells in retinal flatmounts immunostained for Brn3a+. In the ONC model, treatment preserved RGC function, as assessed by pattern electroretinogram, and suppressed retinal inflammation, as assessed by immunofluorescence staining of retinal fixed sections for glial fibrillary acidic protein (GFAP). This is the first study to demonstrate that systemic treatment with NR is protective in acute and chronic models of RGC damage. The protection is significant and, considering that NR is highly bioavailable in and well-tolerated by humans, may support the proposition of prospective human subject studies.
Nicotinamide riboside as a neuroprotective therapy for glaucoma: study protocol for a randomized, double-blind, placebo-control trial. [2022]Whereas lowering the intraocular pressure (IOP) can slow optic nerve degeneration in glaucoma, many patients with glaucoma continue to develop progressive loss in vision despite a significant reduction in IOP. No treatment has been shown to be effective for neuroprotection in glaucoma. We set out to conduct a randomized controlled trial to investigate whether nicotinamide riboside (NR), a nicotinamide adenine dinucleotide precursor, is effective to slow optic nerve degeneration in patients with primary open-angle glaucoma (POAG). We hypothesize that patients treated with NR have a slower rate of progressive retinal nerve fiber layer (RNFL) thinning compared with those treated with placebo.
The Role of NAD+ and Nicotinamide (Vitamin B3) in Glaucoma: A Literature Review. [2022]Glaucoma is a collection of irreversible optic neuropathies which, if left untreated, lead to severe visual field loss. These diseases are a leading cause of blindness across the globe and are estimated to affect approximately 80 million people, particularly women and people of Asian descent (Quigley HA, Broman AT. 2006. Br J Ophthalmol 90: 262-267). This represents a major burden on healthcare systems worldwide. Recently, there has been increasing interest in the potential of nicotinamide (vitamin B3) as a novel option in the management of glaucoma. This review aims to analyse the currently available literature to determine whether there is evidence of an association between nicotinamide adenine dinucleotide (NAD+) and glaucomatous optic neuropathy, and whether nicotinamide has the potential to prevent or reverse these effects. The literature showed a strong connection between reduced NAD+ levels and retinal ganglion cell dysfunction through multiple different studies. There is also evidence of the positive effect of nicotinamide supplementation on retinal ganglion cell function in models of mouse glaucoma and in a study involving humans. Based on the literature findings, a recommendation has been made that more research into the efficacy, appropriate dosing, and potential side effects of nicotinamide supplementation is needed before it can be definitively determined whether it is appropriate for widespread prophylactic and therapeutic use against glaucoma in humans.
The use of Nicotinamide and Nicotinamide riboside as an adjunct therapy in the treatment of glaucoma. [2023]Glaucoma is an optic neuropathy characterized by death of retinal ganglion cells (RGCs), which leads to progressive visual field loss and may result in blindness. Currently, the only available treatment to avoid or delay progression in glaucoma patients is to decrease intraocular pressure (IOP). However, despite adequate IOP control, approximately 25% of the patients continue to progress. To delay or prevent optic nerve damage in glaucoma, two forms of vitamin B3, nicotinamide (NAM) and nicotinamide riboside (NR) are emerging as viable adjuvant therapies. These compounds are nicotinamide adenine dinucleotide (NAD) precursors. NAD is essential for proper cell functioning and is involved in several metabolic activities, including protection against reactive oxygen species, contribution to the performance of various enzymes, and maintenance of mitochondrial function. Due to its beneficial effects and to the evidence of the reduction of NAD bioavailability with aging, researchers are seeking ways to replenish the cellular NAD pool, by administrating its precursors (NAM and NR), believing that it will reduce the RGC vulnerability to external stressors, such as increased IOP. This article attempts to analyze the current knowledge regarding the use of NAM and NR for the prevention and/or treatment of glaucoma.
Nicotinamide Prevents Retinal Vascular Dropout in a Rat Model of Ocular Hypertension and Supports Ocular Blood Supply in Glaucoma Patients. [2023]To investigate whether nicotinamide (NAM) modulates retinal vasculature in glaucoma.