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Trial: NCT00000117 [RDF]

Label NCT00000117
Slug nct00000117
Trialid NCT00000117
Lookup name NCT00000117
Provenance http://clinicaltrials.gov/show/NCT00000117?displayxml=true
Lastchanged date September 16, 2009
Firstreceived results date
Firstreceived date September 23, 1999
Id info nct id NCT00000117
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment
Number of arms
Is section 801
Is fda regulated
Brief title Intravenous Immunoglobulin Therapy in Optic Neuritis
Acronym
Official title
Study type Interventional
Id info nct alias
Completion date December 1997
Verification date September 2009
Why stopped
Id info org study id NEI-13
Required header url https://clinicaltrials.gov/show/NCT00000117
Study design Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Source National Eye Institute (NEI)
Primary completion date
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 07, 2016
Phase Phase 3
Start date August 1995
Has expanded access No
Biospec descr
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 often associated with eye pain. Visual loss may be complete. Spontaneous recovery usually begins within 4 weeks, and marked recovery occurs within 1 to 3 months in most patients. Although clinical improvement is the rule, not all patients recover fully, and many are left with residual symptoms. Although there are limited pathological studies in inflammatory ON, the pathological changes are thought to be virtually identical with those seen in MS, with disruption of the blood-nerve (brain) barrier; primary demyelination with axonal sparing; variable degrees of lymphocytic infiltration; an abundance of macrophages around the inflammatory demyelination lesion; various degrees of remyelination; and, later, oligodendrocyte loss, axonal loss, and gliosis. Remyelination by oligodendrocytes occurs early in the MS lesion, as documented by myelin sheaths that are abnormally thin relative to axon diameter. These thin myelin sheaths are often seen prominently at the edge of demyelinated plaques. A recent series of studies has shown that within weeks of the initial event, there is extensive oligodendrocyte regeneration and remyelination. These immature oligodendrocytes express a series of developmentally restricted antigens. This finding has been interpreted to suggest that the cells that repopulate the acute plaque and that affect remyelination are newly generated and not residual, mature oligodendrocytes. These observations support the possibility that factors that promote remyelination could be used to improve clinical recovery in ON and MS. Work at the Mayo Clinic, has shown that both immunoglobulin G (IgG) directed against spinal cord antigens and purified polyclonal mouse IgG administered systemically promote extensive remyelination in SJL mice chronically infected with Theiler's virus. In addition, tissue culture studies suggest that IgG directed against CNS components may promote oligodendroglial proliferation and differentiation. Thus, experimental evidence exists for the concept that immunoglobulins may stimulate the proliferation and differentiation of oligodendrocytes. It is possible that myelin components on the surface of oligodendrocytes could function as receptors or components of receptors. Antibodies could mimic endogenous ligands, thereby inducing the proliferation or differentiation of these cells. In a preliminary, open-label pilot study of patients with chronic, steroid-unresponsive ON, Drs. van Engelen, Hommes, and colleagues suggested that improvement in visual recovery could be seen following IgG treatment in patients with chronic, stable ON. These encouraging but preliminary basic and clinical studies have prompted us to design a double-blind and placebo-controlled clinical trial of IVIg in patients with recently acquired but apparently permanent muscle paralysis from MS (NS31506) and to develop this NEI-funded ON study (U10EY1096301). In this randomized, placebo-controlled, double-blind clinical trial, 60 patients were assigned to receive either IVIg or a placebo over a period of 3 months. In order to be eligible, patients who meet the inclusion criteria needed to have a stable loss of visual function (unchanged between the pre-enrollment screening visit and the enrollment visit). All patients wre re-examined at 3, 6, 9, and 12 months, with the primary outcome being the impact of treatment on visual acuity at 6 months as determined by measurements on a retroilluminated Early Treatment Diabetic Retinopathy Study chart at 4 meters. One group of patients received 0.4 g/kg Gammimmune N intravenously daily for 5 days, and thereafter once a month for 3 months (total: eight infusions). The other group of patients received infusions of 0.1 percent human serum albumin in 10 percent maltose (placebo) according to the identical protocol used for Gammimmune N. The primary outcome measure was improvement in Logmar visual acuity by an average of 0.2 at 6 months. The secondary outcome measures included change in visual acuity at 3, 9, and 12 months, as determined on a retroilluminated ETDRS chart at 4 meters; change in visual fields at 6 and 12 months; change in visual evoked responses at 3, 6, and 12 months; and change in neurological examination (EDSS, FS, AI) at 3, 6, 9, and 12 months.
Condition browse 6f37b5c41cd44d6011fc2db377faf929
Intervention browse 47c525df542e292cd77cfba265ef7bbb
Responsible party None
Overall contact None
Overall contact backup None
Sponsor group 3320c85d1d94c1dcc49fba09449fce25
Oversight info United States: Federal Government (Oversight_info)
Eligibility 83e879fa36f93afa66b7fe211ad30eee
Keywords None
Conditions Optic Neuritis
Locations 693d2d54b3c6c378bddb2b74b500e91a, feffb29d03f4b4198abbd6aebea7f0c6
Links None
Results references None
Arm groups None
Location countries United States
Interventions Immunoglobulin (Intervention)
Secondary outcomes None
References None
Primary outcomes None
Removed countries None
Overall officials None