Randomized Phase 3 Trial Comparing Early versus Rescue Plasma Exchange Treatment for Severe Optic Neuritis and Transverse Myelitis in Adults

What this Trial Is About

Researchers are evaluating whether starting Therapeutic Plasma Exchange PLEX early compared to using it as a rescue treatment leads to better outcomes for adults with severe Optic Neuritis or severe Transverse Myelitis. The study focuses on whether early PLEX improves visual function and neurological disability. This Phase 3 randomized controlled trial is open-label with rater-blinding and aims to assess treatment timing effects in these inflammatory conditions. Participants receive high-dose corticosteroids HDCS initially, given either intravenously or orally for 5 days. Those in the early PLEX group start PLEX concurrently with HDCS, while those in the rescue group may receive PLEX later if corticosteroids alone are insufficient. PLEX consists of 5 sessions over 5 to 10 days, exchanging 1-1.5 plasma volumes per session. The study includes separate sub-trials for Optic Neuritis and Transverse Myelitis, enrolling adults within 8 days of symptom onset. During the study, participants undergo assessments including visual acuity tests, disability scoring, retinal imaging, and quality of life questionnaires at 6 months. Researchers monitor complications related to PLEX in the first month. The study tracks various neurological and ocular outcomes to understand the impact of early versus rescue PLEX. Participants are expected to comply with study procedures and be available for the duration of the trial, with outcomes measured primarily at 6 months.

Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)