The Glaucoma Nicotinamide Trial (TGNT)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    660
  • sponsor
    Umeå University
Updated on 19 June 2022
corrected visual acuity
glaucoma
tension
trabeculectomy
laser trabeculoplasty
pseudoexfoliation glaucoma
selective laser trabeculoplasty
Accepts healthy volunteers

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.

Description

The treatment arms that included patients will be randomized into are either Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards or true placebo tablets. A major difference between the SGNT and VBIGS is that in SGNT untreated newly diagnosed glaucoma patients will be included whereas in VBIGS glaucoma patients with intraocular pressure lowering treatment will be included. Also, in SGNT an additional non-blinded arm with healthy subjects will receive Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards. For participants where both eyes are eligible, both will be included.

The primary endpoint is visual field progression change over two years.

Details
Condition Glaucoma
Treatment Placebo, Nicotinamide
Clinical Study IdentifierNCT05275738
SponsorUmeå University
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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