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.
Original language | English (US) |
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Pages (from-to) | 1514-1522 |
Number of pages | 9 |
Journal | Neurology |
Volume | 56 |
Issue number | 11 |
DOIs | |
State | Published - Jun 12 2001 |
ASJC Scopus subject areas
- Clinical Neurology