Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Last updated: June 18, 2021
Sponsor: Asociación para Evitar la Ceguera en México
Overall Status: Active - Recruiting

Phase

2/3

Condition

Eye Disorders/infections

Vision Loss

Treatment

N/A

Clinical Study ID

NCT04942002
Neu-21-01
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Both genres
  • Age between 18 and 85 years old.
  • Optic neuritis diagnosis ( relative afferent pupillary defect, acquireddyschromatopsia, low vision, prechiasmatic campimetric defect)
  • 1 month after symptoms started
  • If is a bilateral simultaneous optic neuritis the eye with the worst vision will beincluded.
  • if is a bilateral sequential optic neuritis the eye with lees 1 month evolution willbe included.

Exclusion

Exclusion Criteria:

  • Visual field better than 20/60 at the beginning of the study.
  • History of optic neuritis in the eye under study.
  • History of additional ophthalmological or neurological pathology that has causedvisual loss in the eye under study.
  • History of previous treatment with intravenous methylprednisolone since the onset ofsymptoms.
  • History of high myopia.

Study Design

Total Participants: 50
Study Start date:
June 15, 2021
Estimated Completion Date:
September 15, 2023

Study Description

A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.

Enrollment: 50. Randomized groups (2)

  1. Standard treatment + placebo

  2. Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned

Connect with a study center

  • Jorge Cárdenas Belaunzarán

    Ciudad de mexico, 04030
    Mexico

    Active - Recruiting

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