Status:

COMPLETED

Intravenous Immunoglobulin Therapy in Optic Neuritis

Lead Sponsor:

National Eye Institute (NEI)

Conditions:

Optic Neuritis

Eligibility:

All Genders

Up to 50 years

Phase:

PHASE3

Brief Summary

To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than placebo in restoring lost visual function (visual acuity) in optic neuritis (ON). To determine the time course ...

Detailed Description

Optic neuritis is the leading cause of transient, spontaneous, reversible visual loss in young adults. Characteristically, patients present with central visual loss that peaks within a few days and is...

Eligibility Criteria

To be eligible, patients must have a history of one or more episodes of previous demyelinating optic neuritis occurring in the setting of classic, adult-onset definite MS (clinically definite or laboratory-supported definite MS, or cranial MRI changes consistent with MS). In most cases, onset of MS will have occurred between the ages of 18 and 45. Patients must be younger than 50 years and must have apparently irreversible loss of visual acuity that meets the following criteria:

Visual acuity must be worse than 20/40 for at least 6 months. Patients must be able to read at least one letter on the 1-meter eye chart. Patients with no light perception or hand movement vision only are not eligible.

The above level of visual dysfunction must be observed on at least two serial examinations (separated by at least 1 month) in the Department of Ophthalmology at the Mayo Clinic.

Optic disc pallor must be present.

Patients must have impairment in the affected eye(s) on perimetry consistent with optic nerve dysfunction and must have a visual field mean deviation of less than -4.00.

Patients must not have received ACTH or corticosteroids within the preceding 2 months.

Key Trial Info

Start Date :

August 1 1995

Trial Type :

INTERVENTIONAL

End Date :

December 1 1997

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00000117

Start Date

August 1 1995

End Date

December 1 1997

Last Update

September 17 2009

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

Mayo Clinic, Department of Neurology

Rochester, Minnesota, United States

2

Mayo Clinic

Rochester, Minnesota, United States

Intravenous Immunoglobulin Therapy in Optic Neuritis | DecenTrialz