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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03586557
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Wei Shihui, Chinese PLA General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Optic Neuritis Device: Corticosteroid & Plasma exchange Drug: Corticosteroid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a open-labeled randomized comparison study
Masking: Single (Outcomes Assessor)
Masking Description: Outcome Assessor was masked to avoid measured bias
Primary Purpose: Treatment
Official Title: Effectiveness of Plasma Exchange in Treating With Severe Acute AQP4-Ab Positive Optic Neuritis
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: Corticosteroid & Plasma Exchange
1000mg intravenous methylprednisolone daily for 3~5 days and subsequent taper, combined with plasma exchange every other day for five times in all
Device: Corticosteroid & Plasma exchange
High-dose intravenous methylprednisolone 1000mg 3~5 days and subsequent taper, combined simultaneous plasma exchange 5 times in all
Other Name: CS+PE

Active Comparator: Corticosteroid
1000mg intravenous methylprednisolone daily for 3~5 days, and subsequent corticosteroid decrement.
Drug: Corticosteroid
High-dose intravenous methylprednisolone 1000mg 3~5 days and subsequent taper
Other Name: CS




Primary Outcome Measures :
  1. Visual Acuity (LogMAR) [ Time Frame: from baseline to 6 months ]
    the differences in Visual Acuity outcomes between treatment arm and control arm

  2. Change in OCT parameters over time [ Time Frame: baseline to 6 months ]
    Difference in mean thickness of peripapillary retinal nerve fiber layer and macular Ganglion Cell Complex between treatment group and control group


Secondary Outcome Measures :
  1. Change in Flash Visual Evoked Potential over time [ Time Frame: baseline to 6 month ]
    Difference in P2 peak time and value between treatment group and control group

  2. rate of recurrence over time [ Time Frame: baseline to 6 months ]
    the differences in rate of recurrence (number of recurrence patients / number of patients in their arms) between treatment group and control group

  3. change in serum AQP4-IgG titer over time [ Time Frame: baseline to 6 months ]
    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

  4. orbital MRI [ Time Frame: baseline to 6 months ]
    orbital MRI will be assessed if it is necessary


Other Outcome Measures:
  1. Blood Pressure [ Time Frame: baseline, during PE treatment and followed up at one, three and six months ]
    the change of Blood Pressure at baseline, during PE treatment and follow up

  2. Heart Rate [ Time Frame: baseline, during PE treatment and followed up at one, three and six months ]
    the change of Heart Rate at baseline, during PE treatment and follow up

  3. Rooting Blood Test [ Time Frame: baseline, during PE treatment and followed up at one, three and six months ]
    the change of Rooting Blood Test outcome at baseline, during PE treatment and follow up

  4. Coagulation test [ Time Frame: baseline, during PE treatment and followed up at one, three and six months ]
    the change of Coagulation test outcome at baseline, during PE treatment and follow up

  5. Serum electrolyte [ Time Frame: baseline, during PE treatment and followed up at one, three and six months ]
    the change of Serum electrolyte at baseline, during PE treatment and follow up

  6. side effects [ Time Frame: baseline to 6 months ]
    record the side effects during the period of PE treatment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586557


Contacts
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Contact: Shihui Wei, MD +86 13910079431 weishihui706@hotmail.com
Contact: Mo Yang, PhD +86 18310098349 doctoryangmo@icloud.com

Locations
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China, Beijing
People's Liberation of Army General Hospital (PLAGH) Recruiting
Beijing, Beijing, China, 100853
Contact: Shihui Wei, MD    +86-13910079431    weishihui706@hotmail.com   
Contact: Mo Yang, PhD    +86-18310098349    doctoryangmo@icloud.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Quangang Xu, PhD Chinese PLA General Hospital
Principal Investigator: Huanfen Zhou, PhD Chinese PLA General Hospital
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Responsible Party: Wei Shihui, Professor of Neuro-Ophthalmology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03586557    
Other Study ID Numbers: PETON
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wei Shihui, Chinese PLA General Hospital:
Optic Neuritis
aquaporin4-IgG
Treatment
Additional relevant MeSH terms:
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Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases