Overview

Intravenous Immunoglobulin Therapy in Optic Neuritis

Status:
Completed
Trial end date:
1997-12-01
Target enrollment:
0
Participant gender:
All
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 of recovery following IVIg administration. If the reports of IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can be confirmed, this would provide indirect evidence that IVIg may promote central nervous system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).
Phase:
Phase 3
Details
Lead Sponsor:
National Eye Institute (NEI)
Treatments:
Antibodies
gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
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.