NCT00000117

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1995

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

First QC Date

September 23, 1999

Last Update Submit

September 16, 2009

Conditions

Optic Neuritis

Interventions

ImmunoglobulinDRUG

Eligibility Criteria

AgeUp to 50 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic, Department of Neurology

Rochester, Minnesota, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

MeSH Terms

Conditions

Optic Neuritis

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

August 1, 1995

Study Completion

December 1, 1997

Last Updated

September 17, 2009

Record last verified: 2009-09

Locations

US(2)