Phase III Trial of Nicotinamide With Standard Treatment to Slow Vision Loss in Adults With Open-Angle Glaucoma

What this Trial Is About

Glaucoma is a common eye disease leading to permanent vision loss and blindness, especially among people over 50 years old. Open-angle glaucoma OAG develops slowly as fluid drainage in the eye becomes blocked, increasing eye pressure and damaging the optic nerve. This trial investigates whether adding oral nicotinamide a form of Vitamin B3 to standard pressure-lowering treatments can reduce vision loss in recently diagnosed OAG patients and evaluates the long-term safety and effectiveness of nicotinamide. Participants will be randomly assigned to one of two groups one receiving nicotinamide and the other a matching placebo, both alongside their usual care for lowering eye pressure. The treatment lasts up to 27 months, starting with 1.5 grams per day of nicotinamide or placebo for six weeks, then increasing to 3.0 grams per day for the rest of the period. This study is double-masked, so neither participants nor investigators know which treatment is given. During the trial, participants will undergo regular eye exams including visual field tests to measure vision changes up to 27 months. Researchers will also assess quality of life, liver and kidney function, blood glucose, and record any adverse events. These assessments will help determine the impact of nicotinamide on slowing vision loss and its safety profile over time.

Nicotinamide in Glaucoma (NAMinG): A Randomised, Placebo-controlled, Multi-centre, Phase III Trial