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

NCT03586557 | Unknown

• 1 other identifier: PETON
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Neuritis

Keywords

Optic Neuritis; aquaporin4-IgG; Treatment

Outcome Measures

Primary Outcomes (2)

• Visual Acuity (LogMAR)

  the differences in Visual Acuity outcomes between treatment arm and control arm

  from baseline to 6 months

• 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 Outcomes (4)

• Change in Flash Visual Evoked Potential over time

  baseline to 6 month

• 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

Other Outcomes (6)

• Blood Pressure

  baseline, during PE treatment and followed up at one, three and six months

• Heart Rate

  baseline, during PE treatment and followed up at one, three and six months

• Rooting Blood Test

  baseline, during PE treatment and followed up at one, three and six months

Study Arms (2)

Corticosteroid & Plasma Exchange

EXPERIMENTAL

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

Corticosteroid

ACTIVE COMPARATOR

1000mg intravenous methylprednisolone daily for 3\~5 days, and subsequent corticosteroid decrement.

Drug: Corticosteroid

Interventions

Corticosteroid & Plasma exchange DEVICE

High-dose intravenous methylprednisolone 1000mg 3\~5 days and subsequent taper, combined simultaneous plasma exchange 5 times in all

Also known as: CS+PE

Corticosteroid & Plasma Exchange

Corticosteroid DRUG

High-dose intravenous methylprednisolone 1000mg 3\~5 days and subsequent taper

Also known as: CS

Corticosteroid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 to 70 years old
• Serum AQP4-IgG positive optic neuritis
• Patients must have their VA less than 20/200
• Course of disease is less than 1 month
• Patients must provide written informed consent

You may not qualify if:

• Females who are pregnancy
• Patients who are severely allergic to plasma or albumin
• Patients who have systemic disease and can not accept PE
• Patients with a tendency to thrombus

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

People's Liberation of Army General Hospital (PLAGH)

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Optic Neuritis

Interventions

Plasma Exchange; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Quangang Xu, PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Huanfen Zhou, PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shihui Wei, MD

CONTACT

+86 13910079431; weishihui706@hotmail.com

Mo Yang, PhD

CONTACT

+86 18310098349; doctoryangmo@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessor was masked to avoid measured bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neuro-Ophthalmology

Model Details: a open-labeled randomized comparison study

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 13, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)