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: J H Noseworthy, P C O'Brien, T M Petterson, J Weis, L Stevens, W K Peterson, D Sneve, S A Cross, J A Leavitt, R G Auger, B G Weinshenker, D W Dodick, D M Wingerchuk, M Rodriguez
• Journal: Neurology (Neurology) Vol. 56 Issue 11 Pg. 1514-22 (Jun 12 2001) ISSN: 0028-3878 [Print] United States
• PMID: 11402108 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Immunoglobulins, Intravenous

Topics

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