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The Glaucoma Nicotinamide Trial (TGNT)

Primary Purpose

Glaucoma

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Nicotinamide

Placebo

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Neuroprotection, Glaucoma, Nicotinamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

S:t Eriks Eye HospitalRecruiting
Umeå UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nicotinamide

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual field progression

Change in rate of progression between the two study arms

Secondary Outcome Measures

Full Information

NCT ID

NCT05275738

First Posted

March 2, 2022

Last Updated

July 25, 2023

Sponsor

Umeå University

Collaborators

Centre 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

1. Study Identification

Unique Protocol Identification Number

NCT05275738

Brief Title

The Glaucoma Nicotinamide Trial

Acronym

TGNT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 18, 2022 (Actual)

Primary Completion Date

December 31, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Umeå University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Neuroprotection, Glaucoma, Nicotinamide

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Both patients, care givers and investigators are masked to the treatment

Allocation

Randomized

Enrollment

660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nicotinamide

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Nicotinamide

Intervention Description

Study tablets for nicotinamide are produced by Blackmores Ltd.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Study tablets for placebo are produced by Blackmores Ltd.

Primary Outcome Measure Information:

Title

Visual field progression

Description

Change in rate of progression between the two study arms

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gauti Jóhannesson

Phone

+46907850000

gauti.johannesson@umu.se

Facility Information:

Facility Name

S:t Eriks Eye Hospital

City

Stockholm

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amelie Botling Taube

Facility Name

Umeå University

City

Umeå

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gauti Johannesson

12. IPD Sharing Statement

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The Glaucoma Nicotinamide Trial

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