The Glaucoma Nicotinamide Trial

Last updated: July 25, 2023
Sponsor: Umeå University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Nicotinamide

Placebo

Clinical Study ID

NCT05275738
TGNT
VBIGS
SGNT
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

SGNT: Inclusion Criteria:

  • Adult participants (>18 years) with newly-diagnosed and previously untreated POAG orPEXG 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/abnormaloptic 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 lossesand <15% false positives

Exclusion

Exclusion Criteria:

  • VF damage worse than -10dB in the best eye and -16dB in the worse eye or a paracentralspot 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 cellcarcinoma),
  • 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 affectthe VF, •inability to understand and speak Swedish or English,
  • a history of intraocular surgery (apart from uncomplicated cataract surgery) and
  • diseases that are known to affect retinal function (e.g. > mild age-related maculardegeneration, > stage I diabetic retinopathy). VBIGS: Inclusion Criteria:
  • Patients aged 18 years or older, with definitive, treated POAG including normaltension 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 peoplewith moderate disease which optimises detection of progression.
  • Patient must have performed at least two reliable VFs (24-2), with <33% fixationlosses 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 thestudy. 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 orglaucoma filtration surgery in last 6 months.

Study Design

Total Participants: 660
Treatment Group(s): 2
Primary Treatment: Nicotinamide
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • S:t Eriks Eye Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • Umeå University

    Umeå,
    Sweden

    Active - Recruiting

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