Nicotinamide treatment for open-angle glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Queen Victoria Hospital NHS Foundation Trust
  East Grinstead, United Kingdom Recruiting
• Moorfields Eye Hospital NHS Foundation Trust
  London, United Kingdom Recruiting
• King's College Hospital NHS Foundation Trust
  London, United Kingdom Recruiting
• Queen Alexandra Hospital
  Portsmouth, United Kingdom Recruiting
• 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

Study contacts

• Principal investigator: David Garway-Heath — Ucl
• Study coordinator: NAMinG Trial Team
• Email: cctu.naming@ucl.ac.uk
• Phone: 0203 108 6148

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing Hydrus Microstent and Goniotomy for Glaucoma Treatment

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• Comparing two treatments for glaucoma with cataract

  This study is testing whether a new surgery for glaucoma combined with cataract removal works as well as the usual surgery plus eye drops for people with both conditions.

  Recruiting Sun Yat-sen University · Guangzhou, Guangdong · NCT06201455

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.