Intravenous Immunoglobulin Therapy in Optic Neuritis

This study has been completed.
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00000117
First received: September 23, 1999
Last updated: September 16, 2009
Last verified: September 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Study Start Date: August 1995
Study Completion Date: December 1997
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000117

Locations
United States, Minnesota
Mayo Clinic, Department of Neurology
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000117     History of Changes
Other Study ID Numbers: NEI-13
Study First Received: September 23, 1999
Last Updated: September 16, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014