VBIGS 2023 trial participants with glaucoma 18+

Funding

Charities/Societies/Foundations,Glaucoma Australia

Scientific enquiries

Dr Flora Hui

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 n .... 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.
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Key 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 -3 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 la .... • 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 -3 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.
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Key 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