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Recruiting NCT05275738

The Glaucoma Nicotinamide Trial

Trial Parameters

Condition Glaucoma
Sponsor Umeå University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 660
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-05-18
Completion 2026-12-31
Interventions
NicotinamidePlacebo

Brief Summary

The Glaucoma Nicotinamide Trial (TGNT) is a prospective, randomized, placebo-controlled double-masked clinical trial composed of two cohorts; The Swedish Glaucoma Nicotinamide Trial (SGNT) and the Vitamin B3 In Glaucoma Study (VBIGS). Patients with open-angle glaucoma (OAG) will be randomized to receive either Nicotinamide or placebo through block randomization stratified by glaucoma subtype with a 1:1 allocation.

Eligibility Criteria

SGNT: Inclusion Criteria: * Adult participants (\>18 years) with newly-diagnosed and previously untreated POAG or PEXG in one or both eyes. Glaucoma is defined as reproducible visual field (VF) defects that cannot be explained by other disease or damage, and a suspect/abnormal optic nerve head and/or nerve fibre layer defect. * Participants need to have visual acuity of Snellen ≥ 6/12 (0.5) or better. * Have performed at least two reliable VFs (SITA-Fast 24-2), with \<33% fixation losses and \<15% false positives Exclusion Criteria: * VF damage worse than -10dB in the best eye and -16dB in the worse eye or a paracentral spot with -10dB or less in any eye), * IOP \>35mmHg in any eye or a mean IOP of 30mmHg or higher (two measurements), •inability to perform VFs, * pregnancy/breastfeeding, * those unwilling to abstain from NAM supplements, * allergic to NAM/niacin, * diagnosed with cancer in the last 5 years (except treated basal or squamous cell carcinoma), * a history of liver disease

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