Nicotinamide Supplementation in Glaucoma

Launched by SINGAPORE EYE RESEARCH INSTITUTE · Dec 9, 2024

Keywords

ClinConnect Summary

520 subjects with glaucoma will be enrolled (260 per study arm) from Singapore National Eye Centre and National University Hospital Eye Clinic.

The TAMING Glaucoma Study is designed as a phase 3, randomised, placebo-controlled, double-masked, superiority trial with two parallel groups and a primary endpoint of change in visual field progression over two-three years.

Participants who are currently on NAM will be asked to stop taking the tablets for a month prior to screening visit.

The study duration and your follow-up will be approximately 2-3 years. Recruitment: All participants will be...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged ³ 21 years, with definitive, treated POAG, PACG including normal tension glaucoma, PDG, PXFG in one or both eyes.
• • Best-corrected visual acuity equal or better than 6/18
• • Reproducible visual field defect due to glaucoma (3 contiguous points at less than 5%) and severity of visual field loss, MD between -2 and -18 dB. This range includes people with moderate disease which optimises detection of progression.
• • Patients must have at least two prior 24-2 VF tests which meet \<16% FP and \<21% fixation loss.
• • Previous selective laser trabeculoplasty is acceptable (IOP-lowering laser treatment) if ³ 3 months prior or filtering surgery \>6 months previously.
• • Normal liver function tests.
• • Those taking NAM already will undergo a 1-month washout period bef
• Exclusion Criteria:
• • Patients with active liver disease or end stage renal failure.
• • Active use of allopurinol, carbamazepine, or primidone.
• • Visually significant cataracts (example, likely to require surgery within 2 years).
• • Cataract surgery in the last 3 months or glaucoma filtration surgery in last 6 months.
• • Conditions that may cause non-glaucomatous visual field defect (for example, severe ptosis, cerebrovascular accident, prior panretinal photocoagulation, and other retinal or central nervous system diseases).
• • Not able to complete study (for example, concurrent severe systemic disease).
• • History of cancer in the last 5 years.
• • Unable to give consent.
• • Inability to tolerate or take nicotinamide and/or pyruvate.
• • Women of Child Bearing Potential, pregnancy or lactation.
• • History of Hypotension
• • Blood Pressure measurement of less than 90/60(