Actively Recruiting
The Glaucoma Nicotinamide Trial
Led by Umeå University · Updated on 2023-07-27
660
Participants Needed
2
Research Sites
241 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
C
Center for Eye Research Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Glaucoma Nicotinamide Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants (>18 years) with newly diagnosed and untreated primary open-angle glaucoma or pseudoexfoliation glaucoma in one or both eyes (SGNT)
- Visual acuity of Snellen ≥ 6/12 (0.5) or better (SGNT)
- Performed at least two reliable visual fields with <33% fixation losses and <15% false positives (SGNT)
- Patients aged 18 years or older with treated primary open-angle glaucoma including normal tension glaucoma or pseudoexfoliation glaucoma in both eyes (VBIGS)
- Best-corrected visual acuity ≥ 6/18 (VBIGS)
- Visual field loss with mean deviation between -3 and -18 dB (VBIGS)
- Performed at least two reliable visual fields with <33% fixation losses and <15% false positives (VBIGS)
- Previous selective laser trabeculoplasty allowed if done 3 or more months prior with normal liver function tests (VBIGS)
- Participants taking nicotinamide must undergo a 1-month washout before starting the study (VBIGS)
You will not qualify if you...
- Visual field damage worse than -10 dB in the best eye or -16 dB in the worse eye, or a paracentral spot with -10 dB or less in any eye (SGNT)
- Intraocular pressure >35 mmHg in any eye or mean intraocular pressure of 30 mmHg or higher (SGNT)
- Inability to perform visual field tests (SGNT)
- Pregnancy or breastfeeding (SGNT)
- Unwillingness to abstain from nicotinamide supplements (SGNT)
- Allergy to nicotinamide or niacin (SGNT)
- Cancer diagnosis in the last 5 years except treated basal or squamous cell carcinoma (SGNT)
- History of liver disease or stomach ulcers (SGNT)
- Diseases preventing long-term follow-up (SGNT)
- Neurologic or non-glaucomatous conditions affecting visual fields except cataract (SGNT)
- Inability to understand and speak Swedish or English (SGNT)
- History of intraocular surgery except uncomplicated cataract surgery (SGNT)
- Diseases affecting retinal function such as more than mild age-related macular degeneration or more than stage I diabetic retinopathy (SGNT)
- History of hepatic disease, gout, visually significant cataracts, other conditions affecting visual field results (VBIGS)
- Cataract surgery in the last 3 months or glaucoma filtration surgery in the last 6 months (VBIGS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
S:t Eriks Eye Hospital
Stockholm, Sweden
Actively Recruiting
2
Umeå University
Umeå, Sweden
Actively Recruiting
Research Team
G
Gauti Jóhannesson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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