Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis
Primary Purpose
Optic Neuritis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Edaravone
Sponsored by
About this trial
This is an interventional treatment trial for Optic Neuritis
Eligibility Criteria
Inclusion Criteria:
- Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis
- Patients with a first episode of optic neuritis in either eye
- First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone
Exclusion Criteria:
- Myopia over 6 diopters
- Refractive media opacity affecting assessment of retinal layers and/or visual acuity
Sites / Locations
- Yi DuRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Edaravone
Arm Description
Outcomes
Primary Outcome Measures
Best-corrected visual acuity
Best-corrected visual acuity will be measured by "Illiterate E"chart.
Secondary Outcome Measures
Ganglion cell-inner plexiform layer
Ganglion cell-inner plexiform layer will be measured by optical coherence tomography.
Peripapillary retinal nerve fiber layer
Peripapillary retinal nerve fiber layer will be measured by optical coherence tomography.
Full Information
NCT ID
NCT05540262
First Posted
September 11, 2022
Last Updated
January 10, 2023
Sponsor
First Affiliated Hospital of Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05540262
Brief Title
Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis
Official Title
Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Guangxi Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Edaravone showed a good effect on promoting remyelination and protecting axons in NMOSD animals. The investigators hypothesize that edaravone can inhibit axonal damage in patients with aquaporin-4 antibody-positive optic neuritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Edaravone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Edaravone
Intervention Description
Edaravone injection 30mg three times a day
Primary Outcome Measure Information:
Title
Best-corrected visual acuity
Description
Best-corrected visual acuity will be measured by "Illiterate E"chart.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Ganglion cell-inner plexiform layer
Description
Ganglion cell-inner plexiform layer will be measured by optical coherence tomography.
Time Frame
18 months
Title
Peripapillary retinal nerve fiber layer
Description
Peripapillary retinal nerve fiber layer will be measured by optical coherence tomography.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis
Patients with a first episode of optic neuritis in either eye
First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone
Exclusion Criteria:
Myopia over 6 diopters
Refractive media opacity affecting assessment of retinal layers and/or visual acuity
Facility Information:
Facility Name
Yi Du
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Du, MD
Phone
+86 771 5356507
Email
duyinapoleon@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis
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