Optic Neuritis Clinical Trial
Official title:
Effectiveness of Plasma Exchange in Treating With Severe Acute AQP4-Ab Positive Optic Neuritis
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.
Status | Recruiting |
Enrollment | 142 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | People's Liberation of Army General Hospital (PLAGH) | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood Pressure | the change of Blood Pressure at baseline, during PE treatment and follow up | baseline, during PE treatment and followed up at one, three and six months | |
Other | Heart Rate | the change of Heart Rate at baseline, during PE treatment and follow up | baseline, during PE treatment and followed up at one, three and six months | |
Other | Rooting Blood Test | the change of Rooting Blood Test outcome at baseline, during PE treatment and follow up | baseline, during PE treatment and followed up at one, three and six months | |
Other | Coagulation test | the change of Coagulation test outcome at baseline, during PE treatment and follow up | baseline, during PE treatment and followed up at one, three and six months | |
Other | Serum electrolyte | the change of Serum electrolyte at baseline, during PE treatment and follow up | baseline, during PE treatment and followed up at one, three and six months | |
Other | side effects | record the side effects during the period of PE treatment | baseline to 6 months | |
Primary | Visual Acuity (LogMAR) | the differences in Visual Acuity outcomes between treatment arm and control arm | from baseline to 6 months | |
Primary | Change in OCT parameters over time | Difference in mean thickness of peripapillary retinal nerve fiber layer and macular Ganglion Cell Complex between treatment group and control group | baseline to 6 months | |
Secondary | Change in Flash Visual Evoked Potential over time | Difference in P2 peak time and value between treatment group and control group | baseline to 6 month | |
Secondary | rate of recurrence over time | the differences in rate of recurrence (number of recurrence patients / number of patients in their arms) between treatment group and control group | baseline to 6 months | |
Secondary | change in serum AQP4-IgG titer over time | compare the different changes in serum AQP4-IgG titer (before treatment and 6 months follow-up) between PE combined corticosteroid group and only corticosteroid group | baseline to 6 months | |
Secondary | orbital MRI | orbital MRI will be assessed if it is necessary | baseline to 6 months |
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