Study of Privosegtor and Standard Treatment for Adults Aged 18 to 50 With First Episode of Optic Neuritis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of privosegtor, a neuroprotective drug candidate, in adults diagnosed with optic neuritis ON, a condition causing visual loss. This Phase 3 clinical trial compares the combination of privosegtor and standard care methylprednisolone against a placebo plus standard care to assess their impact on vision recovery. Participants will receive either privosegtor at 3 mgkgday intravenously or a placebo solution intravenously for 5 days, along with methylprednisolone 1 gday intravenously for 5 days as standard care. The study is randomized, double-masked, and placebo-controlled to ensure unbiased evaluation of the treatments. Throughout the study, participants will undergo assessments including low contrast visual acuity tests and measurements of retinal layer thickness and serum neurofilament light chain levels. The primary outcome focuses on the proportion of participants gaining significant improvement in vision after 3 months. The total study duration extends through to December 2028, with safety and efficacy monitored closely during this period.

Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research