A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)

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). The study compares privosegtor combined with standard care (methylprednisolone) against a placebo plus standard care to better understand their impact on vision recovery. This is a Phase 3, randomized, double-masked, placebo-controlled trial sponsored by Oculis. Participants will receive either privosegtor (3 mg/kg/day intravenously) or placebo (0.9% sodium chloride solution intravenously) for five days, alongside methylprednisolone (1 g/day intravenously) for the same duration as standard treatment. The trial involves two main groups: one receiving the experimental drug and one receiving placebo, both with the standard care medication. During the study, participants will be monitored for improvements in low contrast visual acuity (LCVA), changes in retinal layer thickness, and serum neurofilament light chain levels over three months. Safety and vision outcomes are assessed at multiple time points, with the primary measurement being the proportion of participants gaining at least 15 letters in LCVA three months after treatment. The total participation period and follow-up details align with these assessment timelines.

Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research