A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis

John 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, Brian G Weinshenker, David William Dodick, Dean Marko Wingerchuk, M. Rodriguez

Research output: Contribution to journalArticle

139 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)1514-1522
Number of pages9
JournalNeurology
Volume56
Issue number11
StatePublished - Jun 12 2001

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Optic Neuritis
Intravenous Immunoglobulins
National Eye Institute (U.S.)
Placebos
Vision Disorders
Visual Fields
Double-Blind Method
Outcome Assessment (Health Care)
Therapeutics

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Noseworthy, J. H., O'Brien, P. C., Petterson, T. M., Weis, J., Stevens, L., Peterson, W. K., ... Rodriguez, M. (2001). A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis. Neurology, 56(11), 1514-1522.

A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis. / Noseworthy, John H.; O'Brien, P. C.; Petterson, T. M.; Weis, J.; Stevens, L.; Peterson, W. K.; Sneve, D.; Cross, S. A.; Leavitt, J. A.; Auger, R. G.; Weinshenker, Brian G; Dodick, David William; Wingerchuk, Dean Marko; Rodriguez, M.

In: Neurology, Vol. 56, No. 11, 12.06.2001, p. 1514-1522.

Research output: Contribution to journalArticle

Noseworthy, JH, O'Brien, PC, Petterson, TM, Weis, J, Stevens, L, Peterson, WK, Sneve, D, Cross, SA, Leavitt, JA, Auger, RG, Weinshenker, BG, Dodick, DW, Wingerchuk, DM & Rodriguez, M 2001, 'A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis', Neurology, vol. 56, no. 11, pp. 1514-1522.
Noseworthy JH, O'Brien PC, Petterson TM, Weis J, Stevens L, Peterson WK et al. A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis. Neurology. 2001 Jun 12;56(11):1514-1522.
Noseworthy, John H. ; O'Brien, P. C. ; Petterson, T. M. ; Weis, J. ; Stevens, L. ; Peterson, W. K. ; Sneve, D. ; Cross, S. A. ; Leavitt, J. A. ; Auger, R. G. ; Weinshenker, Brian G ; Dodick, David William ; Wingerchuk, Dean Marko ; Rodriguez, M. / A randomized trial of intravenous immunoglobulin in inflammatory demyelinating optic neuritis. In: Neurology. 2001 ; Vol. 56, No. 11. pp. 1514-1522.
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AU - Stevens, L.

AU - Peterson, W. K.

AU - Sneve, D.

AU - Cross, S. A.

AU - Leavitt, J. A.

AU - Auger, R. G.

AU - Weinshenker, Brian G

AU - Dodick, David William

AU - Wingerchuk, Dean Marko

AU - Rodriguez, M.

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N2 - 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.

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