Pilot Study of Efgartigimod Alfa with Steroids to Treat First-Time Moderate to Severe Acute Optic Neuritis in Adults

What this Trial Is About

This research aims to evaluate efgartigimod alfa compared to placebo in adults experiencing their first episode of optic neuritis, which is inflammation of the optic nerve. The study investigates whether efgartigimod alfa is feasible to use for optic neuritis, if conducting a larger trial is possible, and how the treatment affects the speed and extent of vision recovery. This is a pilot, randomized, placebo-controlled clinical trial led by Anastasia Vishnevetsky, MD, MPH. Participants are randomly assigned to one of two groups one group receives efgartigimod alfa, and the other receives a placebo. Both groups also receive standard care treatment consisting of high-dose corticosteroids for 3 days followed by a prednisone taper over 3 weeks. Efgartigimod alfa or placebo is given by subcutaneous injection on Day 0 and Day 3. If needed, rescue therapy with plasma exchange is available based on evaluation results on Day 7. Throughout the 6-month study period, participants will have multiple visits where their vision is tested and blood samples are taken. They will also answer questions about their vision. Researchers will measure changes in high and low contrast visual acuity at 1 month and up to 6 months, monitor safety, and track adherence and retention. The study includes standard care and careful monitoring to understand the treatments effects on vision recovery and quality of life.

Efgartigimod for the Treatment of Acute Optic Neuritis