title: A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis.
abstract: OBJECTIVE
  To determine whether IV immunoglobulin (IVIg) reverses chronic visual impairment in MS patients with optic neuritis (ON).
  
  
  METHODS
  In this double-blind, placebo-controlled Phase II trial, 55 patients with persistent acuity loss after ON were randomized to receive either IVIg 0.4 g/kg daily for 5 days followed by three single infusions monthly for 3 months, or placebo.
  
  
  RESULTS
  The trial was terminated by the National Eye Institute because of negative results when 55 of the planned 60 patients had been enrolled. Fifty-two patients completed the scheduled infusions, and 53 patients completed 12 months of follow-up. Analysis of this data indicated that a difference between treatment groups was not observed for the primary outcome measure, improvement in logMAR visual scores at 6 months (p = 0.766). Exploratory secondary analyses suggested that IVIg treatment was associated with improvement in visual function (including logMAR visual scores at 6 months and visual fields at 6 and 12 months) in patients with clinically stable MS during the trial.
  
  
  CONCLUSIONS
  IVIg administration does not reverse persistent visual loss from ON to a degree that merits general use.
authors.affiliation: Department of Neurology, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. noseworthy.john@mayo.edu
authors.forename: J H
authors.initials: JH
authors.lastname: Noseworthy
authors.forename: P C
authors.initials: PC
authors.lastname: O'Brien
authors.forename: T M
authors.initials: TM
authors.lastname: Petterson
authors.forename: J
authors.initials: J
authors.lastname: Weis
authors.forename: L
authors.initials: L
authors.lastname: Stevens
authors.forename: W K
authors.initials: WK
authors.lastname: Peterson
authors.forename: D
authors.initials: D
authors.lastname: Sneve
authors.forename: S A
authors.initials: SA
authors.lastname: Cross
authors.forename: J A
authors.initials: JA
authors.lastname: Leavitt
authors.forename: R G
authors.initials: RG
authors.lastname: Auger
authors.forename: B G
authors.initials: BG
authors.lastname: Weinshenker
authors.forename: D W
authors.initials: DW
authors.lastname: Dodick
authors.forename: D M
authors.initials: DM
authors.lastname: Wingerchuk
authors.forename: M
authors.initials: M
authors.lastname: Rodriguez
mesh_terms: D000328:Adult; D002908:Chronic Disease; D020278:Demyelinating Autoimmune Diseases, CNS / Q000276:immunology / Q000628:therapy*; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009902:Optic Neuritis / Q000276:immunology / Q000628:therapy*; D020127:Recovery of Function; D016896:Treatment Outcome; D015354:Vision, Low / Q000276:immunology / Q000628:therapy; D014792:Visual Acuity; D014794:Visual Fields
chemical_list: D016756:Immunoglobulins, Intravenous