Nicotinamide for Glaucoma
(NADIR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a vitamin B3 supplement, nicotinamide, can protect the eye's nerve cells in individuals with primary open-angle glaucoma (POAG). Participants will either continue their usual glaucoma treatment or add nicotinamide, and researchers will compare the eye health of both groups over 12 months. The study seeks individuals diagnosed with POAG who are already using eye drops or have undergone laser treatment to manage their glaucoma. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Is there any evidence suggesting that nicotinamide is likely to be safe for humans?
Research has shown that high-dose nicotinamide, a type of vitamin B3, is usually safe for people. Studies have found that taking up to 1 gram per day is often safe for long-term use. In this trial, participants will start with 1.5 grams and may increase to 3 grams per day.
A review of high-dose nicotinamide found it to be safe, with most people not experiencing serious side effects. Some might encounter mild issues like an upset stomach. Before increasing the dose, the trial will check for any liver problems to ensure participants can handle the dose without major issues.
Overall, current evidence suggests that nicotinamide is safe and well-tolerated at the doses used in this study.12345Why do researchers think this study treatment might be promising for glaucoma?
Unlike the standard glaucoma treatments, which primarily focus on lowering intraocular pressure with medications like prostaglandin analogs or using laser therapy, high-dose oral nicotinamide takes a different approach. This treatment uses nicotinamide, a form of vitamin B3, which may protect the cells in your eyes from damage by boosting their energy levels and resilience. Researchers are excited because this method could provide a new layer of protection for the optic nerve, potentially slowing the progression of glaucoma more effectively than current options.
What evidence suggests that nicotinamide might be an effective treatment for glaucoma?
Research has shown that nicotinamide, a type of vitamin B3, might help protect against glaucoma. In this trial, one group of participants will receive high-dose oral nicotinamide along with standard glaucoma care. One study found that patients taking high doses of nicotinamide experienced noticeable vision improvements over 12 weeks. Another study found that 93% of eyes in mice did not develop glaucoma when given nicotinamide. Research on humans also suggests that it can reduce the risk of glaucoma in people with high eye pressure. These findings indicate that nicotinamide might slow the progression of glaucoma by protecting the nerve cells in the eye.678910
Who Is on the Research Team?
Steven C Quan, OD
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with primary open-angle glaucoma who are already using standard glaucoma treatments like eye drops or laser therapy. Participants should not have other major eye diseases or health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive high-dose oral nicotinamide in addition to standard glaucoma care, with dose titration from 1.5 g/day to 3.0 g/day over 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and retinal imaging
What Are the Treatments Tested in This Trial?
Interventions
- Nicotinamide
Trial Overview
The study tests if adding high-dose nicotinamide (vitamin B3) tablets to regular glaucoma treatment can better protect retinal nerve cells compared to standard care alone. Participants are randomly assigned to either receive the supplement or just continue their usual treatment for 12 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive immediate-release oral nicotinamide titrated from 1.5 g/day (500 mg three times daily with meals, Weeks 1 through 6) to 3.0 g/day (1,500 mg twice daily \[three 500 mg tablets per administration, twice daily\] with meals, Week 7 through Month 12), in addition to individualized standard glaucoma therapy. Dose advancement at Week 7 requires confirmation at the Month 1 remote safety contact that no Grade 2 or higher hepatic adverse event is present and gastrointestinal tolerability is acceptable.
Participants receive individualized intraocular pressure-lowering therapy per the AAO Primary Open-Angle Glaucoma Preferred Practice Pattern, which may include topical IOP-lowering medications (e.g., prostaglandin analogs) and/or selective laser trabeculoplasty, with monitoring by optical coherence tomography, perimetry, and intraocular pressure measurement at 3 to 6 month intervals. No supplemental nicotinamide is administered.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Citations
Niacinamide and Neuroprotection: The Glaucoma Holy Grail
Williams et al. reported that at the lowest and the highest doses tested (equivalent to ~2.7 gm/day and ~9.8 gm/day for a 60 kg human), NAM was very effective ...
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.
3.
facebook.com
facebook.com/medscape/posts/among-patients-with-high-eye-pressure-those-who-took-vitamin-b3-nicotinamide-sup/1981985845772834/Among patients with high eye pressure, those who took ...
A large observational study suggests that nicotinamide (vitamin B3) may help lower the risk of developing primary open-angle glaucoma, the most ...
The Efficacy of Nicotinamide in Maintaining Mean ...
Mean Vmax improved by 12.6% in the treatment group vs 3.6% in the placebo group after 12 weeks (p = 0.03), and mean PhNR Vmax improved by 14.8% ...
5.
glaucoma.org
glaucoma.org/articles/the-powerhouse-of-vision-how-mitochondria-are-linked-to-glaucomaThe Powerhouse Of Vision: How Mitochondria Are Linked ...
Later, a 2020 study found that glaucoma patients who took a high dose of nicotinamide for 12 weeks showed significant improvements in their ...
Improvement in Inner Retinal Function in Glaucoma with ...
Vitamin B3 modulates mitochondrial vulnerability and prevents glaucoma in aged mice. Safety of high-dose nicotinamide: a review.
7.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05275738/the-glaucoma-nicotinamide-trialThe Glaucoma Nicotinamide Trial | Clinical Research ...
Severity of visual field loss, MD between -3 and -18 dB. Patient must have performed at least two reliable VFs (24-2), with <33% fixationlosses ...
8.
nordiclifescience.org
nordiclifescience.org/vitamin-b3-improves-visual-function-in-glaucoma-patients/Vitamin B3 improves visual function in glaucoma patients
Nicotinamide improved glaucoma patients' visual function. The results of the current study show significant improvement in the visual function ...
Williams et al. report that vitamin B3 (niacin) prevents eye ...
At the highest dose tested, 93% of eyes did not develop glaucoma. This supports therapeutic use of vitamin B3 in glaucoma and potentially other age-related ...
10.
digital.mivision.com.au
digital.mivision.com.au/collections/mivision-magazine-march-2025/fine-line-on-nicotinamide-for-glaucoma-1o26Fine Line on Nicotinamide for Glaucoma
“Multiple studies have confirmed that doses up to 1 g daily are generally well tolerated, even when taken over the long term” Because there ...
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