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RecruitingNCT05275738TGNTUpdated Jul 27, 2023

The Glaucoma Nicotinamide Trial

An interventional study of Nicotinamide and Placebo in Glaucoma, sponsored by Umeå University. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Umeå University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
660
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Glaucoma

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Keywords

  • Neuroprotection
  • Glaucoma
  • Nicotinamide
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 660 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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 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
  • diseases that are known to affect retinal function (e.g. > mild age-related macular degeneration, > stage I diabetic retinopathy).

VBIGS:

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
660 participants (estimated)

Study arms

  • Active comparator
    Nicotinamide

    Participants will receive 750mg nicotinamide tablets 1+1 per day (1.5g) for 6 weeks and after that 2+2 per day (3.0g).

    Dietary Supplement: Nicotinamide

  • Placebo comparator
    Placebo

    Participants will receive 750mg placebo tablets 1+1 per day for 6 weeks and after that 2+2 per day.

    Other: Placebo

Interventions

  • Dietary supplementNicotinamide

    Study tablets for nicotinamide are produced by Blackmores Ltd.

  • OtherPlacebo

    Study tablets for placebo are produced by Blackmores Ltd.

06

What researchers measure

Primary outcomes

  1. Visual field progression

    Change in rate of progression between the two study arms

    Time frame: Two years

07

Study locations

2 of 2 sites recruiting
  • S:t Eriks Eye Hospital
    Stockholm, Sweden
    • Amelie Botling Taube · Contact
    Recruiting
  • Umeå University
    Umeå, Sweden
    • Gauti Johannesson · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05275738
Lead sponsor
Umeå University
Collaborators
Center for Eye Research Australia, Karolinska Institutet, Singapore National Eye Centre, Duke-NUS Graduate Medical School, University of Melbourne, University of Adelaide, Lund University, Linkoeping University, Göteborg University
Responsible party
Sponsor
First posted
Mar 11, 2022
Start date
May 18, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 27, 2023

Study contacts

Gauti Jóhannesson
Contact
gauti.johannesson@umu.se
+46907850000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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