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January 21, 1992
Clinical Alert to Ophthalmologists and Neurologists who Treat Patients with Optic Neuritis
This letter is to inform you of findings from the Optic Neuritis Treatment Trial that warrant your attention prior to publication of the results. This randomized, multicenter clinical trial was supported by the National Eye Institute, a component of the National Institutes of Health (NIH).
The trial evaluated the safety and efficacy of corticosteroid treatment in over 450 patients with optic neuritis. It found that oral prednisone (prescribed in a dosage of 1 mg/kg/day for 14 days) was not only ineffective in speeding recovery or in improving the visual outcome after optic neuritis, but actually increased a patient's risk for future attacks in either the affected or fellow eye.
Specifically, trial investigators found that 27 percent of the patients taking oral prednisone had at least one new attack of optic neuritis during follow-up, which for some patients was as long as two years. In contrast, patients who received an oral placebo had a 15 percent rate of subsequent optic neuritis.
Based on these findings, the trial investigators have concluded that there is no role for oral prednisone alone in standard dosages in the treatment of patients with initial episodes of optic neuritis.
The complete findings from this study will be published soon. This announcement is being sent in advance of journal publication to ophthalmologists and neurologists likely to treat patients with optic neuritis. A list of participating centers is included on the back of this sheet for your reference.
Carl Kupfer, M.D.
National Eye Institute
Roy W. Beck, M.D.
Optic Neuritis Treatment Trial
Professor of Ophthalmology
University of South Florida