Tests nicotinamide, a vitamin B3 supplement, against placebo in glaucoma
Tests nicotinamide, a vitamin supplement, in adults with open-angle glaucoma.
Plain-language title generated from the registry record
Registry title: The Glaucoma Nicotinamide Trial
Key facts
- Where
- Stockholm and Umeå, SwedenSee the 2 sites
Where in Sweden
- S:t Eriks Eye HospitalStockholm, SwedenTaking people
- Umeå UniversityUmeå, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Umeå University
- Trial code
- NCT05275738
- Record updated
- 27 July 2023
- Original description
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.Read full original descriptionShow less
The Glaucoma Nicotinamide Trial - A Prospective, Randomized, Placebo-controlled, Double-masked Trial
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.
Inclusion: 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; Patients aged 18 years or older, with definitive, treated POAG including normal tension glaucoma, PEXG in both eyes; Best-corrected visual acuity ≥ 6/18; Severity of visual field loss, MD between -3 and -18 dB. This range includes people with moderate disease which optimises detection of progression; Patient must have performed at least two reliable VFs (24-2), with <33% fixation losses and <15% false positives; Previous selective laser trabeculoplasty is acceptable (IOP-lowering laser treatment) if 3 or more months prior, and normal liver function tests; Those taking NAM already will undergo a 1-month washout period before commencing the study.
Exclusion: allergic to NAM/niacin,; diagnosed with cancer in the last 5 years (except treated basal or squamous cell carcinoma),; a history of liver disease or stomach ulcers,; disease that prevents long-term follow-up,; neurologic or other non-glaucomatous conditions apart from cataract that may affect the VF, •inability to understand and speak Swedish or English,; a history of intraocular surgery (apart from uncomplicated cataract surgery) and; Patients with a history of hepatic disease, gout, visually significant cataracts, other conditions that can affect VF results, cataract surgery in the last 3 months or glaucoma filtration surgery in last 6 months; diseases that are known to affect retinal function (e.g. > mild age-related macular degeneration, > stage I diabetic retinopathy); VBIGS:; 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,.
SGNT:.