RecruitingPhase 3ACTRN12622000414718

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


Sponsor

Centre for Eye Research Australia

Enrollment

424 participants

Start Date

Jan 31, 2023

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Glaucoma is a leading cause of blindness worldwide, slowly and silently damaging the optic nerve and stealing peripheral vision. It cannot yet be cured, and while eye drops to lower pressure are the standard treatment, many patients continue to lose vision despite treatment. Researchers are urgently seeking new ways to protect the nerve cells in the eye. Vitamin B3 (nicotinamide) has emerged as a promising neuroprotective supplement that may help maintain the health of optic nerve cells. Building on an earlier world-first trial that showed promising results, this Phase 3 study will test whether taking nicotinamide daily for two years slows the rate of vision loss in people with glaucoma, compared to a placebo. Visual field tests and eye imaging will be performed every 4 months. You may be eligible if you are an adult with diagnosed and treated primary open-angle glaucoma, normal tension glaucoma, or pseudoexfoliative glaucoma in both eyes, with moderate severity of visual field loss (specific measurement criteria apply), and adequate vision. People with significant liver disease, visually significant cataracts, or recent glaucoma surgery are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 gra

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)

SA,VIC, Australia

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ACTRN12622000414718


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