Nicotinamide treatment for open-angle glaucoma
A Phase III, Double-masked, Randomised, Placebo-controlled Trial Investigating the Safety and Efficacy of Nicotinamide (NAM) to Slow Visual Field Loss in Adults With Open-angle Glaucoma
This study is testing if a form of Vitamin B3 called Nicotinamide can help people with early to moderate open-angle glaucoma keep their vision from getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 496 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 10 sites (Belfast, Northern Ireland and 9 other locations) |
| Trial ID | NCT05405868 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Nicotinamide, a form of Vitamin B3, on patients diagnosed with early to moderate open-angle glaucoma. The study aims to evaluate whether boosting mitochondrial function with Nicotinamide can slow the progression of glaucoma and preserve vision. Participants will be randomly assigned to receive either Nicotinamide or a matching placebo, with assessments of safety and efficacy conducted throughout the trial. The research focuses on understanding the neuroprotective mechanisms of Nicotinamide in relation to intraocular pressure and optic nerve health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who have been recently diagnosed with early to moderate open-angle glaucoma.
Not a fit: Patients with pigment dispersion glaucoma or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce vision loss in glaucoma patients and improve their quality of life.
How similar studies have performed: While there is evidence supporting the neuroprotective role of Nicotinamide in animal models, this approach in humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have been recently diagnosed (within the last 12 months) with early to moderate open-angle glaucoma (OAG) in at least one eye (including primary OAG, normal tension glaucoma (NTG) and pseudoexfoliation glaucoma) 2. Open angle on gonioscopy 3. Adults aged 18 years or over 4. Snellen visual acuity 6/12 or better in at least one eye meeting the visual field (VF) criteria 5. Visual Field (VF) mean deviation (MD) no worse than -12dB in either eye 6. A negative pregnancy test result at the screening and baseline visit prior to randomisation for women of childbearing potential 7. Ability to provide informed consent to participate 8. Able and willing to attend trial visits and comply with trial procedures for the duration of the trial Exclusion Criteria: 1. Pigment dispersion glaucoma 2. Pregnancy (or planned pregnancy during the trial) and/or breastfeeding 3. Women of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraception for the duration of the trial treatment and for the time period specified following last trial treatment administration. 4. Current treatment with either isoniazid, pyrazinamide, carbamazepine, phenobarbital or primidone 5. Current liver disease or laboratory results with elevated levels of liver transaminases (AST or ALT \>3 x ULN) at screening visit. 6. Renal failure (eGFR \<30mL/min/1.73m²) at screening visit. 7. Conditions affecting both eyes which may affect the Visual Field test result: 1. Diabetic retinopathy or any other retinal disease causing VF loss 2. Clinically relevant cataract (likely to require cataract surgery within the next 2 years) 3. Dementia or other non-glaucomatous neurological disease causing VF loss 4. Adnexal conditions causing VF loss (including but not limited to blepharochalasis) 8. Diagnosed with cancer in the last 5 years (with exception of non-melanoma skin cancer). 9. Any clinical condition that, in the investigator's opinion would make the participant unsuitable for the trial. 10. Concurrently enrolled in any other interventional trial or participation in previous clinical trial of glaucoma. 11. Current use of, and unwilling to abstain from, over-the-counter additional vitamin B3/NAM oral supplements (including skin preparations such as ointments/emulsions), Ginkgo Biloba and/or Coenzyme Q10 supplements, throughout the duration of their participation in the trial.
Where this trial is running
Belfast, Northern Ireland and 9 other locations
- Belfast City Hospital — Belfast, Northern Ireland, United Kingdom (Not_yet_recruiting)
- Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Not_yet_recruiting)
- Queen Victoria Hospital NHS Foundation Trust — East Grinstead, United Kingdom (Recruiting)
- Royal Liverpool Hospital — Liverpool, United Kingdom (Not_yet_recruiting)
- Moorfields Eye Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- Barnet Hospital, Royal Free London NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- Manchester Royal Eye Hospital — Manchester, United Kingdom (Not_yet_recruiting)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (Not_yet_recruiting)
- Queen Alexandra Hospital — Portsmouth, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David Garway-Heath — Ucl
- Study coordinator: NAMinG Trial Team
- Email: cctu.naming@ucl.ac.uk
- Phone: 0203 108 6148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.