Effectiveness of Plasma Exchange in Treating With Severe Acute AQP4-Ab Positive Optic Neuritis
We could not find results for this trial
I know where the results areWhat it 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
VisionChange 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 repairrate 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
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History
Started
Sept 2018
Main results due
Dec 2021
Finished
Dec 2021
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