A Randomized Controlled, Open-Label, Rater-Blinded Pragmatic Trial, Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
Mayo Clinic
Summary
The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Study Population and Setting The proposal will recruit participants presenting to participating sites with severe ON or severe TM to two separate sub-trials. The detailed inclusion and exclusion criteria for each sub-trial are listed below: Optic Neuritis Sub-Trial: Inclusion criteria: * ≥18 years of age * MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis * Visual acuity 20/200 or worse * Within 8 days of onset of visual symptoms * Able to initiate PLEX within 72h…