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| Sponsored by: |
National Eye Institute (NEI) |
|---|---|
| Information provided by: | National Eye Institute (NEI) |
| ClinicalTrials.gov Identifier: | NCT00000117 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Optic Neuritis |
Drug: Immunoglobulin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Eligibility| Ages Eligible for Study: | up to 50 Years |
| Genders Eligible for Study: | Both |
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.
Contacts and Locations More Information
| Study ID Numbers: | NEI-13 |
| Study First Received: | September 23, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000117 |
| Health Authority: | United States: Federal Government |
|
Papillitis Antibodies Neuromuscular Diseases Immunoglobulins, Intravenous Eye Diseases Peripheral Nervous System Diseases |
Rho(D) Immune Globulin Optic Nerve Diseases Optic nerve disorder Immunoglobulins Optic Neuritis Neuritis |
|
Immunologic Factors Physiological Effects of Drugs Nervous System Diseases Cranial Nerve Diseases Pharmacologic Actions |
