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

ConditionsOptic NeuritisMyelitisMyelitis, Transverse
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

≥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 14 days of onset of visual symptoms

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-dose corticosteroids (HDCS)

    Drug

    Subjects will receive initial treatment with high-dose corticosteroids (HDCS) in the form of methylprednisolone (1,000mg daily) administered intravenously for 5 days or a bioequivalent dose of oral corticosteroids (e.g., 1,250mg prednisone daily or 176mg dexamethasone daily). Subjects will be escalated to PLEX if there is an insufficient response to HDCS (decision point at 14±2 days for the ON sub-trial and 7±1 days for the TM sub-trial) PLEX will be performed as 5 sessions over 5-10 days, with 1-1.5 plasma volumes exchanged per session.

  • High-dose corticosteroids (HDCS) and PLEX

    Drug

    Subjects will receive treatment with high-dose corticosteroids (HDCS) and PLEX initiated concurrently. HDCS will be administered in the form of methylprednisolone (1,000mg daily) administered intravenously for 5 days or a bioequivalent dose of oral corticosteroids (e.g., 1,250mg prednisone daily or 176mg dexamethasone daily). PLEX will be performed as 5 sessions over 5-10 days, with 1-1.5 plasma volumes exchanged per session.

Treatment groups

382 Participants
are divided into 4 treatment groups
Group A: Optic Neuritis (ON) "Rescue PLEX"Active comparator 1 intervention
Group B: Optic Neuritis (ON) "Early PLEX"Experimental treatment 1 intervention
Group C: Transverse Myelitis "Rescue PLEX"Active comparator 1 intervention
Group D: Transverse Myelitis "Early PLEX"Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

High contrast visual acuity

The Optic Neuritis subjects will have high contrast visual acuity measured by ETDRS 100% high-contrast Sloan letter charts. A high contrast visual acuity of 20/20 is considered "normal," a high contrast visual acuity of 20/40 or better is required to be able to drive without restrictions, and a high contrast visual acuity of 20/200 or worse is considered legally blind.

Time frame
6 months
2

Expanded Disability Status Score (EDSS)

The level of disability in Transverse Myelitis subjects will be assessed using the Expanded Disability Status Scale (EDSS). The EDSS assesses various neurological functional systems, including pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cereberal functions and ranges from 0 (normal neurological examination) to 10 (death). Higher scores indicate greater disability. Visual and cerebral functional system scores will be excluded from the EDSS calculation for quantification of Transverse Myelitis-related disability.

Time frame
6 months

Secondary outcomes

1

Low contrast (2.5%) visual acuity

Optic Neuritis subjects will have low contrast visual acuity (best corrected) assessed with 2.5% low-contrast Sloan letter charts

Time frame
6 months
2

Peri-papillary retinal nerve fiber layer (RNFL thickness)

Optic Neuritis subjects will have RNFL thickness measured via Retinal Optical Coherence Tomography (OCT).

Time frame
6 months
3

Macular ganglion cell-inner plexiform layer (GCIPL) thicknesses

Optic Neuritis subjects will have GCIPL thickness measured via Retinal Optical Coherence Tomography (OCT).

Time frame
6 months
4

Hardy Rand and Rittler (HRR) color plates

The Hardy-Rand-Rittler (HRR) color plates test will be administered to Optic Neuritis subjects. The HRR is scored based on the number of correct responses to the diagnostic plates, with the total number of correct figures out of 28 being the primary score.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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