Nicotinamide in Glaucoma (NAMinG)
Glaucoma, Open-Angle
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Nicotinamide, Vitamin B3
Eligibility Criteria
Inclusion Criteria:
- 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)
- Open angle on gonioscopy
- Adults aged 18 years or over
- Snellen visual acuity 6/12 or better in at least one eye meeting the visual field (VF) criteria
- Visual Field (VF) mean deviation (MD) no worse than -12dB in either eye
- A negative pregnancy test result at the screening and baseline visit prior to randomisation for women of childbearing potential
- Ability to provide informed consent to participate
- Able and willing to attend trial visits and comply with trial procedures for the duration of the trial
Exclusion Criteria:
- Pigment dispersion glaucoma
- Pregnancy (or planned pregnancy during the trial) and/or breastfeeding
- 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.
- Current treatment with isoniazid or pyrazinamide or carbamazepine
- Current liver disease or laboratory results with elevated levels of transaminases (AST or ALT >3 x ULN) at screening visit.
- Renal failure (eGFR <30mL/min/1.73m²) at screening visit.
Conditions affecting both eyes which may affect the Visual Field test result:
- Diabetic retinopathy or any other retinal disease causing VF loss
- Clinically relevant cataract (likely to require cataract surgery within the next 2 years)
- Dementia or other non-glaucomatous neurological disease causing VF loss
- Adnexal conditions causing VF loss (including but not limited to blepharochalasis)
- Any clinical condition that, in the investigator's opinion would make the participant unsuitable for the trial.
- Concurrently enrolled in any other interventional trial or participation in previous clinical trial of glaucoma.
- Current use of, or 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.
Sites / Locations
- Belfast City Hospital
- Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
- Queen Victoria Hospital NHS Foundation Trust
- Royal Liverpool Hospital
- Moorfields Eye Hospital NHS Foundation Trust
- Barnet Hospital, Royal Free London NHS Foundation Trust
- King's College Hospital NHS Foundation Trust
- Manchester Royal Eye Hospital
- Nottingham University Hospitals NHS Trust
- Queen Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Nicotinamide
Matching Placebo
Participants will receive Nicotinamide for up to 27 months (treatment period) in addition to an initial treatment of Standard of Care IOP- lowering therapy (prior to randomisation and start of trial treatment) . They will receive 1.5g/day for the first 6 weeks, then dose increase to 3.0g/day for remainder of the treatment period.
Participants will receive matching placebo for up to 27 months (treatment period) in addition to an initial treatment of Standard of Care IOP- lowering therapy (prior to randomisation and start of trial treatment) . They will receive 1.5g/day for the first 6 weeks, then dose increase to 3.0g/day for remainder of the treatment period.