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NCT03586557

Effectiveness of Plasma Exchange in Treating With Severe Acute AQP4-Ab Positive Optic Neuritis

Status unknown NA Last updated 17 August 2021
What this trial tests

NA trial testing Corticosteroid & Plasma exchange in Optic Neuritis in 142 participants. Status unknown.

Timeline
1 September 2018
Primary endpoint
31 December 2021
31 December 2021

Quick facts

Lead sponsorChinese PLA General Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment142
Start date1 September 2018
Primary completion31 December 2021
Estimated completion31 December 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Chinese PLA General Hospital

Who can join

Adults 18 to 70, any sex, with Optic Neuritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients aged between 18 and 70 with acute aquaporin-4 immunoglobulin G antibodies (AQP4-IgG) positive optic neuritis, irrespective of prior using of corticosteroids in this episode of disease, are chosen by the physician. Patients will then be randomized to receive high dose of intravenous corticosteroids combined with plasma exchange (PE), or merely high dose of intravenous corticosteroids followed subsequent taper. The main outcome of visual acuity and OCT parameters will be compared at baseline, one, three and six months after treatments, and other assessments will also be recorded and compared. This will allow for determination on whether additional PE plays a role in better prognosis in acute AQP4-IgG positive optic neuritis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Leveraging Visual Outcome Measures to Advance Therapy Development in Neuroimmunologic Disorders.
    Graves JS, Oertel FC, Van der Walt A, Collorone S, et al · · 2022 · cited 45× · PMID 34955459 · DOI 10.1212/nxi.0000000000001126

Verify or expand the search:

Other recruiting trials for Optic Neuritis

Currently open trials in the same condition.

Other Chinese PLA General Hospital trials

Trials by the same sponsor.

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Data sources for this page

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