Clinical Trial: Optic Neuritis Recovery After Oral or IV Corticosteroids

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Recovery of Demyelinating Optic Neuritis After Treatment With Equivalent High Doses of Oral vs. Intravenous Corticosteroids: a Randomized Single Blinded Clinical Trial

Brief Summary: Patients aged 18-65 with acute demyelinating optic neuritis where treatment with high dose corticosteroids are already been chosen by the patient and the diagnosing physician will be contacted for screening and enrollment. Patients will then be randomized to receive equivalent doses of either intravenous (IV) or oral corticosteroid treatment. Optic nerve function assessments will be compared at baseline, prior to treatment, one and six months post corticosteroid treatment. This will allow for a comparison on whether the route of medication plays a role in the effectiveness of treatment with high dose corticosteroids.

Detailed Summary:

This will be a single-blind, randomized comparison study between 1000mg IV methylprednisolone daily for three days and 1250mg oral prednisone daily for three days of the recovery of optic nerve function in acute demyelinating optic neuritis. We will be comparing assessments at baseline, prior to corticosteroid treatment, with assessments at one and six months post corticosteroid treatment.

Patient Population

We propose to study patients with acute demyelinating optic neuritis where treatment with high dose corticosteroids is being considered. This presentation can be either the first presentation of a demyelinating event (CIS) or in a patient with a previous diagnosis of CIS or MS but must be the first presentation of ON in the affected eye.

Subjects will be recruited from out-patients assessed for acute demyelinating optic neuritis by neurology, ophthalmology, neuro-ophthalmology at London Health Sciences Center and St. Joseph's Health Care Center in London, Ontario. Subjects will be included only if the first visit takes place within 14 days of symptom onset. Only subjects where the physician who identifies/diagnoses the optic neuritis is considering corticosteroid treatment will be contacted for potential screening and enrollment. To ensure treatment is chosen based on the clinical judgement of physician diagnosing ON, the investigators will only contact potential subjects after the decision to use corticosteroids has been made by the patient's treating physician.

Primary and Secondary Endpoints

The primary measure will be the P100 latency of the Visual Evoked Potential in the affected eye at six months. Secondary measures will include high contrast visual acuity and contr
Sponsor: London Health Sciences Centre

Current Primary Outcome: P100 latency of the Visual Evoked Potential in the affected eye [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • High contrast visual acuity [ Time Frame: one and six months ]
  • contrast sensitivity [ Time Frame: one and six months ]
  • P100 latency of the Visual Evoked Potential in the affected eye [ Time Frame: one month ]


Original Secondary Outcome: Same as current

Information By: London Health Sciences Centre

Dates:
Date Received: January 30, 2012
Date Started: March 2012
Date Completion:
Last Updated: September 1, 2015
Last Verified: September 2015