Edaravone in the Treatment of Optic Neuritis

February 25, 2025 updated by: Yi Du, First Affiliated Hospital of Guangxi Medical University
Edaravone has demonstrated a beneficial effect in promoting remyelination and protecting axons in animals with NMOSD. The researchers posit that edaravone may enhance visual outcomes in patients with aquaporin-4 antibody-positive optic neuritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis
  2. Patients with a first episode of optic neuritis in either eye
  3. First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone

Exclusion Criteria:

  1. Myopia over 6 diopters
  2. Refractive media opacity affecting assessment of retinal layers and/or visual acuity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edaravone
Drug: Edaravone
Edaravone injection 30mg three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity
Time Frame: 18 months
Best-corrected visual acuity will be measured by "Illiterate E"chart.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ganglion cell-inner plexiform layer
Time Frame: 18 months
Ganglion cell-inner plexiform layer will be measured by optical coherence tomography.
18 months
Peripapillary retinal nerve fiber layer
Time Frame: 18 months
Peripapillary retinal nerve fiber layer will be measured by optical coherence tomography.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 11, 2022

First Submitted That Met QC Criteria

September 11, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GXEDAON1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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