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

Not Applicable

Active, not recruiting

• Conditions: Optic Neuritis; Myelitis; Myelitis, Transverse
• Interventions: Drug: High-dose corticosteroids (HDCS); Drug: High-dose corticosteroids (HDCS) and PLEX

• Registration Number: NCT07100990
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-11
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Primary Completion: 2029-10-01
• Study Completion: 2031-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optic Neuritis (ON) "Rescue PLEX"	High-dose corticosteroids (HDCS)	Adult participants presenting within 8 days of symptom onset with severe Optic Neuritis (ON) (visual acuity of 20/200 or worse
Optic Neuritis (ON) "Early PLEX"	High-dose corticosteroids (HDCS) and PLEX	Adult participants presenting within 8 days of symptom onset with severe Optic Neuritis (ON) (visual acuity of 20/200 or worse
Transverse Myelitis "Rescue PLEX"	High-dose corticosteroids (HDCS)	Adult participants presenting within 8 days of symptom onset with severe Transverse Myelitis (TM) (expanded Disability Status Scale \[EDSS\] of 3.0 or worse)
Transverse Myelitis "Early PLEX"	High-dose corticosteroids (HDCS) and PLEX	Adult participants presenting within 8 days of symptom onset with severe Transverse Myelitis (TM) (expanded Disability Status Scale \[EDSS\] of 3.0 or worse)

Primary Outcome Measures

Name	Time	Method
High contrast visual acuity	6 months	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.
Expanded Disability Status Score (EDSS)	6 months	The level of disability in Transverse Myelitis subjects will be assessed using the Expanded Disability Status Scale (EDSS). The EDSS assesses various functional systems, including pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cognitive functions. Higher scores indicate greater disability.

Secondary Outcome Measures

Name	Time	Method
Macular ganglion cell-inner plexiform layer (GCIPL) thicknesses	6 months	Optic Neuritis subjects will have GCIPL thickness measured via Retinal Optical Coherence Tomography (OCT).
Low contrast (2.5%) visual acuity	6 months	Optic Neuritis subjects will have low contrast visual acuity (best corrected) assessed with 2.5% low-contrast Sloan letter charts
Peri-papillary retinal nerve fiber layer (RNFL thickness)	6 months	Optic Neuritis subjects will have RNFL thickness measured via Retinal Optical Coherence Tomography (OCT).
Hardy Rand and Rittler (HRR) color plates	6 months	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.
National Eye Institute (NEI) 10-Item Neuro-Ophthalmic Supplement	6 months	Optic Neuritis subjects will complete the 10-Item Neuro-Ophthalmic Supplement, a 10-item questionnaire used to assess visual dysfunction in patients with neuro-ophthalmologic disorders. It is scored on a scale of 0 to 100, with higher scores indicating better visual functioning.
Ambulatory disability	6 months	Transverse Myelitis subjects will be assessed for ambulatory disability using the Hauser Ambulation Index, a timed 25 foot, 6 minute walk.
Manual dexterity (Nine-Hole Peg Test)	6 months	The Nine-Hole Peg Test will be administered to the Transverse Myelitis subjects. Subjects will be asked to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. They will then remove the pegs, one by one, from the board as quickly as possible. Scores are based on the time taken to complete the activity and are reported in seconds.
Patient Determined Disease Steps (PDDS)	6 months	Transverse Myelitis subjects will complete the Patient-Determined Disease Steps (PDDS), a self-reported disability scale with 9 levels ranging from no disability to bedridden.
Spinal Cord Injury Quality of Life questionnaire (SCI-QoL)	6 months	Transverse Myelitis subjects will complete the The Spinal Cord Injury Quality of Life questionnaire (SCI-QoL), which includes assessments of specific domains related to bladder/bowel dysfunction, pain, pressure ulcers, mobility/ambulation, fine motor skills, self-care, and wheelchair mobility.
PLEX Complications	2 weeks, 1 month	Total number of adverse events categorized according to the Common Terminology Criteria for Adverse Events v5.0
National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25	6 months	Optic Neuritis subjects will complete the National Eye Institute Visual Functioning Questionnaire-25. The questionnaire consists of 25 items, covering 11 vision-related domains, plus a single global-rating item. Items are scored and converted to a 0- to 100-point scale where higher scores indicate better functioning.

Trial Locations

Locations (2)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States