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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
660
Study tablets for nicotinamide are produced by Blackmores Ltd.
Study tablets for placebo are produced by Blackmores Ltd.
S:t Eriks Eye Hospital
Stockholm, Sweden
RECRUITINGUmeå University
Umeå, Sweden
RECRUITINGVisual field progression
Change in rate of progression between the two study arms
Time frame: Two years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.