A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis.
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.
Noseworthy
J H
JH
Department of Neurology, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. noseworthy.john@mayo.edu
O'Brien
P C
PC
Petterson
T M
TM
Weis
J
J
Stevens
L
L
Peterson
W K
WK
Sneve
D
D
Cross
S A
SA
Leavitt
J A
JA
Auger
R G
RG
Weinshenker
B G
BG
Dodick
D W
DW
Wingerchuk
D M
DM
Rodriguez
M
M
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
D016756:Immunoglobulins, Intravenous