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NCT05540262 Clinical Trial

Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis

Optic Neuritis Clinical Trial

Official title:
Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05540262
Other study ID # GXEDAON1.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source First Affiliated Hospital of Guangxi Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Edaravone
Edaravone injection 30mg three times a day

Locations
Country Name City State
China Yi Du Nanning

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best-corrected visual acuity Best-corrected visual acuity will be measured by "Illiterate E"chart. 18 months
Secondary Ganglion cell-inner plexiform layer Ganglion cell-inner plexiform layer will be measured by optical coherence tomography. 18 months
Secondary Peripapillary retinal nerve fiber layer Peripapillary retinal nerve fiber layer will be measured by optical coherence tomography. 18 months
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