The Vitamin B3 in Glaucoma Study (VBIGS)
The Vitamin B3 in Glaucoma Study (VBIGS): A 2-year Multi-centre, Double-masked, Randomised, Placebo-controlled Trial of Nicotinamide (Vitamin B3) Supplementation in Glaucoma
Centre for Eye Research Australia
424 participants
Jan 31, 2023
Interventional
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria1
- 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
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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 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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12622000414718