None listed
Conditions
Brief summary
This study builds upon our world-first clinical trial of nicotinamide in glaucoma (ACTRN12617000809336) demonstrating the potential protective role of vitamin B3 (nicotinamide) supplements in people with glaucoma. Glaucoma causes progressive loss of nerve tissue in the eye, and irreversible vision loss. This study investigates the effect of taking nicotinamide supplements over 2 years on the eye’s structure and function compared to placebo. The primary aim of this study is to determine whether nicotinamide supplements in participants with glaucoma leads to reduced rate of progression in visual function measured using visual fields over 2 years. Participants diagnosed and treated for glaucoma will be invited to undertake the study. They will be randomly assigned to take nicotinamide or placebo daily for 24 months. Clinical tests including visual fields and imaging of the eye are performed at baseline, and every 4 months post-intervention.
Interventions
International Nonproprietary Name (INN): nicotinamide
Intervention: daily nicotinamide supplementation for 24 months
Dose: accelerated dose from 1.5 grams daily for 6 weeks to 3 grams daily (1.5 grams, twice a day) for the remaining period
Mode of administration: oral tablet, to be taken with food
Adherence monitoring: remaining tablets will be counted at each visit, participants will be asked to log each time they forget a dose. To improve adherence, weekly reminders via phone, e-mail or text
International Nonproprietary Name (INN): nicotinamide Intervention: daily nicotinamide supplementation for 24 months Dose: accelerated dose from 1.5 grams daily for 6 weeks to 3 grams daily (1.5 grams, twice a day) for the remaining period Mode of administration: oral tablet, to be taken with food Adherence monitoring: remaining tablets will be counted at each visit, participants will be asked to log each time they forget a dose. To improve adherence, weekly reminders via phone, e-mail or text message may be sent, and a daily alarm set on participant's phone (if required). A minimum 70% compliance rate will be deemed acceptable, which approximately equates to forgetting to take the intervention twice a week.
Sponsors
Centre for Eye Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults with definitive, treated primary open angle glaucoma (POAG), normal tension glaucoma (NTG) or pseudoexfoliative glaucoma (PXFG) in both eyes • Best-corrected visual acuity of at least 6/18 in each eye • Severity of visual field (VF) loss, mean deviation (MD) between -2 and -18 dB. This range includes people with moderate disease which optimises detection of progression. • Patients must have prior 2-3 x 24-2 VF tests in the past which meet VF reliability criteria. • Previous selective laser trabeculoplasty is acceptable (IOP-lowering laser treatment) if more than 3 months prior, and normal liver function tests. • Those taking nicotinamide (NAM) already will undergo a 1-month washout period before commencing the study.
Exclusion criteria
Adults with a history of hepatic disease, visually significant cataracts, other conditions that can affect visual field results, glaucoma filtration surgery in last 6 months, cataract surgery in the last 3 months
Outcome results
None listed