Intravenous Immunoglobulin Therapy in Optic Neuritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000117
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : September 17, 2009
Information provided by:
National Eye Institute (NEI)

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 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).

Condition or disease Intervention/treatment Phase
Optic Neuritis Drug: Immunoglobulin Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1995
Actual Study Completion Date : December 1997

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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000117

United States, Minnesota
Mayo Clinic, Department of Neurology
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Sponsors and Collaborators
National Eye Institute (NEI) Identifier: NCT00000117     History of Changes
Other Study ID Numbers: NEI-13
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs