Data

VBIGS 2023 trial participants with glaucoma 18+

The University of Melbourne

Dataset description

Clinical and ocular health data measured 4-monthly over 2 years in 424 adult (18+) participants with treated glaucoma at time of enrolment.
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Subjects

Ophthalmology |

Source Study

Trial acronym

VBIGS

Trial ID

ACTRN12622000414718

Purpose

Treatment

Phase

Phase 3

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 ....
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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 ....
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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

Can healthy volunteers participate?

No

 

Population

Sample Size    424

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Glaucoma

Condition code    Eye

Intervention

Intervention code Treatment: Drugs

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 m ....
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Comparison

Control group Placebo

Placebo comparator: Microcrystalline cellulose (matching tablets containing no active ingredients)

Outcomes

Outcome: Changes to rate of visual field progression, specifically visual field sensitivity assessed using perimetry (visual field machine)
Timepoint: Baseline and 24 months after commencement of intervention

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

De-identified participant data underlying published results

When will data be available?

Data will be available following publication. No end date

Available to whom?

Researchers who provide a methodologically sound proposal The trial database may by uploaded to the Health Studies National Data Asset program (HeSANDA) following completion

Available for what types of analyses?

To achieve the aims in the proposal

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au