Status unknownNot a drug-phase studyNMOSDNCT03586557

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Corticosteroid & Plasma exchange

Compared with

  • Corticosteroid

What it measured

Main measures

  • Visual Acuity (LogMAR)

    from baseline to 6 months

    Vision
  • Change in OCT parameters over time

    baseline to 6 months

    Retina scans (OCT)

Other measures (4)

  • Change in Flash Visual Evoked Potential over time

    baseline to 6 month

    Myelin repair
  • rate of recurrence over time

    baseline to 6 months

  • change in serum AQP4-IgG titer over time

    baseline to 6 months

  • orbital MRI

    baseline to 6 months

    MRI lesions

Who could take part

NMOSD · 18 to 70

Inclusion Criteria: 1. Age between 18 to 70 years old 2. Serum AQP4-IgG positive optic neuritis 3. Patients must have their VA less than 20/200 4. Course of disease is less than 1 month 5. Patients must provide written informed consent Exclusion Criteria: 1. Females who are pregnancy 2. Patients who are severely allergic to plasma or albumin 3. Patients who have systemic disease and can not accept PE 4. Patients with a tendency to thrombus

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

    Loading reviews and guidelines…

    Related trials

    History

      1. Started

        Sept 2018

      2. Main results due

        Dec 2021

      3. Finished

        Dec 2021

      Assembled by software from public sources and not checked by people. Each record links to its source. Report an error