A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis

Neurology. 2001 Jun 12;56(11):1514-22. doi: 10.1212/wnl.56.11.1514.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Chronic Disease
  • Demyelinating Autoimmune Diseases, CNS / immunology
  • Demyelinating Autoimmune Diseases, CNS / therapy*
  • Disability Evaluation
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Immunoglobulins, Intravenous / administration & dosage*
  • Male
  • Middle Aged
  • Optic Neuritis / immunology
  • Optic Neuritis / therapy*
  • Recovery of Function
  • Treatment Outcome
  • Vision, Low / immunology
  • Vision, Low / therapy
  • Visual Acuity
  • Visual Fields


  • Immunoglobulins, Intravenous