The Glaucoma Nicotinamide Trial

NCT05275738 | Recruiting

• 3 other identifiers: TGNTSGNTVBIGS
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma

Keywords

Neuroprotection; Glaucoma; Nicotinamide

Outcome Measures

Primary Outcomes (1)

• Visual field progression

  Change in rate of progression between the two study arms

  Two years

Study Arms (2)

Nicotinamide

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Nicotinamide DIETARY_SUPPLEMENT

Study tablets for nicotinamide are produced by Blackmores Ltd.

Nicotinamide

Placebo OTHER

Study tablets for placebo are produced by Blackmores Ltd.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Umeå University: lead
• Center for Eye Research Australia: collaborator
• Karolinska Institutet: collaborator
• Singapore National Eye Centre: collaborator
• Duke-NUS Graduate Medical School: collaborator
• University of Melbourne: collaborator
• University of Adelaide: collaborator
• Lund University: collaborator
• Linkoeping University: collaborator
• Göteborg University: collaborator

Study Sites (2)

S:t Eriks Eye Hospital

Stockholm, Sweden

RECRUITING

Umeå University

Umeå, Sweden

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Gauti Jóhannesson

CONTACT

+46907850000; gauti.johannesson@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both patients, care givers and investigators are masked to the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: May 18, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

SE (2)