Nicotinamide for Glaucoma

(NADIR Trial)

SC
ER
Overseen ByElza Rachid, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

SC

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

My vision in the study eye is 20/40 or better with correction.
I am between 40 and 80 years old.
My eye pressure is 21 mmHg or lower with my current treatment.
See 8 more

Exclusion Criteria

My kidney function is severely reduced (eGFR less than 30).
Pregnancy, lactation, or intent to become pregnant during study period
I have normal tension glaucoma and my eye pressure is always 21 mmHg or lower without medication.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

12 months
Visits at Baseline, Month 1 (remote), Month 3, Month 6, and Month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and retinal imaging

4 weeks

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

Group I: High-Dose Oral Nicotinamide Plus Standard Glaucoma CareExperimental Treatment2 Interventions
Group II: Standard Glaucoma Care Alone (Active Control)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

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.

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% ...

The 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.

The 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 ...

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 ...

Fine 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 ...