Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study
- Conditions
- Primary Open Angle Glaucoma
- Interventions
- Drug: Dietary supplements - Nicotinamide and PyruvateDrug: Placebo
- Registration Number
- NCT05695027
- Lead Sponsor
- Columbia University
- Brief Summary
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).
- Detailed Description
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing or standard automated perimetry (SAP). The natural course of glaucoma includes a decline in visual function that matches optic nerve structural changes over time.
Both in clinical practice and in clinical trials, individuals undergo visual field testing at regular intervals in order to define whether progressive changes have occurred as well as the rapidity of change. Visual field results are highly variable within and between sessions, partly due to its subjective nature, which ultimately depends upon the test reliability, individuals' level of experience with the test, variability due to disease severity, and, importantly, the level of individual attentiveness during the test. Therefore, numerous attempts have been made to try to optimize individuals' performance during the test. Some of the approaches reported to date are listening to classical music mitigating background noise and use of nutritional supplements.
Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. The investigators are doing this research study to find out if taking nutritional supplements (vitamin B3 and pyruvate) available over- the-counter can help slow the rate of glaucomatous visual field progression compared to placebo.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nicotinamide and Pyruvate Dietary supplements - Nicotinamide and Pyruvate The N\&P group will receive nicotinamide and pyruvate for 87 weeks (20 months). Placebo Placebo The placebo group will receive placebo for 87 weeks (20 months).
- Primary Outcome Measures
Name Time Method Change in visual field results based on pointwise and global metrics 87 weeks The primary outcome in this study are changes in visual field results based on pointwise and global metrics between intervention and placebo groups.
Change in retinal nerve fiber and ganglion cell layer thickness 87 weeks The primary outcome in this study are changes in retinal nerve fiber and ganglion cell layer thickness as assessed by optical coherence tomography testing between intervention and placebo groups.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Stanford University Department of Ophthalmology
🇺🇸Palo Alto, California, United States
ColumbiaDoctors Ophthalmology - 880 Third Avenue
🇺🇸New York, New York, United States
Columbia University Irving Medical Center - 622 W 168th St
🇺🇸New York, New York, United States