Nicotinamide and Pyruvate in Open-Angle Glaucoma: A Randomized Controlled Trial on Neuroprotection-Design and...

Area of Science:

• Ophthalmology
• Neuroprotection
• Metabolic pathways in ocular disease

Background:

• Open-angle glaucoma (OAG) is a leading cause of irreversible blindness.
• Current treatments primarily focus on lowering intraocular pressure, but neuroprotection remains a critical unmet need.
• Dietary supplementation with nicotinamide and pyruvate shows potential for metabolic support in ocular tissues.

Purpose of the Study:

• To determine if nicotinamide and pyruvate dietary supplementation offers neuroprotection in patients with treated OAG.
• To evaluate the efficacy and safety of this novel therapeutic approach.

Main Methods:

• A prospective, two-site, phase 3 randomized clinical trial (NIC-OAG Trial).
• 21-month duration, placebo-controlled, double-masked design.
• Participants receive standard OAG treatment plus either 3g/day nicotinamide and 1g/day calcium pyruvate or placebo.

Main Results:

• Primary outcome is a composite of visual field and optical coherence tomography changes.
• Secondary outcomes include tolerability, safety, and identification of responsive patient subgroups.
• Analysis of metabolomics, transcriptomics, and proteomics from blood samples.

Conclusions:

• The NIC-OAG trial is designed to yield significant data on the neuroprotective effects of nicotinamide and pyruvate in glaucoma.
• Findings may enhance understanding of optimal clinical trial designs for glaucoma neuroprotection research.