Status:
COMPLETED
Intravenous Immunoglobulin Therapy in Optic Neuritis
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Optic Neuritis
Eligibility:
All Genders
Up to 50 years
Phase:
PHASE3
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 ...
Detailed Description
Optic neuritis is the leading cause of transient, spontaneous, reversible visual loss in young adults. Characteristically, patients present with central visual loss that peaks within a few days and is...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 1995
Trial Type :
INTERVENTIONAL
End Date :
December 1 1997
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000117
Start Date
August 1 1995
End Date
December 1 1997
Last Update
September 17 2009
Active Locations (2)
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1
Mayo Clinic, Department of Neurology
Rochester, Minnesota, United States
2
Mayo Clinic
Rochester, Minnesota, United States