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NCT Number: NCT05540262

Edaravone in the Treatment of Optic Neuritis

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.

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Key information

Conditions

Optic Neuritis Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edaravone

Drug

Edaravone injection 30mg three times a day

Primary outcomes

  1. Best-corrected visual acuity

    Time frame: 18 months

    Best-corrected visual acuity will be measured by "Illiterate E"chart.

Secondary outcomes

  1. Ganglion cell-inner plexiform layer

    Time frame: 18 months

    Ganglion cell-inner plexiform layer will be measured by optical coherence tomography.

  2. Peripapillary retinal nerve fiber layer

    Time frame: 18 months

    Peripapillary retinal nerve fiber layer will be measured by optical coherence tomography.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2022
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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