The Glaucoma Nicotinamide Trial

Glaucoma Clinical Trial

— TGNT  

Official title:

The Glaucoma Nicotinamide Trial - A Prospective, Randomized, Placebo-controlled, Double-masked Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275738
• Other study ID #: TGNT
• Secondary ID: SGNTVBIGS
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Umeå University
• Contact: Gauti Jóhannesson
• Phone: +46907850000
• Email: gauti.johannesson[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Dietary Supplement:
• Nicotinamide
Study tablets for nicotinamide are produced by Blackmores Ltd.

Other:
• Placebo
Study tablets for placebo are produced by Blackmores Ltd.

Locations

Country	Name	City	State
Sweden	S:t Eriks Eye Hospital	Stockholm
Sweden	Umeå University	Umeå

Sponsors (10)

Lead Sponsor	Collaborator
Umeå University	Centre for Eye Research Australia, Duke-NUS Graduate Medical School, Göteborg University, Karolinska Institutet, Linkoeping University, Lund University, Singapore National Eye Centre, University of Adelaide, University of Melbourne

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual field progression	Change in rate of progression between the two study arms	Two years