NCT05275738Recruiting
The Glaucoma Nicotinamide Trial
The Glaucoma Nicotinamide Trial - A Prospective, Randomized, Placebo-controlled, Double-masked Trial
Source: ClinicalTrials.gov · Last updated 27 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- First submitted
- 2 Mar 2022
- Start date
- 18 May 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Umeå University
- Diseases
- Glaucoma
- NCT number
- NCT05275738
What you commit to
- Study type: Interventional
- Planned participants: 660
- From 18 May 2022 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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.
Age
- diseases that are known to affect retinal function (e.g. \> mild age-related macular degeneration, \> stage I diabetic retinopathy).
- VBIGS:
Other
- 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,
Who the study is looking for
- 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
- 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.
Criteria the registry did not label
- SGNT:
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| S:t Eriks Eye Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Umeå University Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.