The goal of this study is to evaluate the safety and potential therapeutic activity of humanized anti-IL-2 receptor monoclonal antibody (Daclizumab) therapy in the treatment of patients with severe, sight-threatening, intermediate and posterior non-infectious uveitis.This is a non-randomized, open-label, pilot study. Patients with chronic, non-infectious bilateral, sight-threatening uveitis who were treated with a minimum of 20 mg of prednisone, cyclosporine, anti-metabolites, or any combination of these agents were eligible. Patients were weaned off these immunosuppressive agents according to a standardized schedule, while ultimately receiving Daclizumab infusions every 4 weeks.Anti-Interleukin 2 receptor antibody therapy, given intravenously with intervals of up to four weeks in lieu of standard immunosuppressive therapy, appeared to prevent the expression of severe sight-threatening intraocular inflammatory disease in nine of ten patients treated for a minimum of seven months, based on the primary end point of a loss of vision of 10 letters or more from baseline in either eye. All patients were able to tolerate the study medications without the need for dose reduction. We continue to follow these patients long term.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Intramural Research (Z01)
Project #
1Z01EY000321-02
Application #
6432480
Study Section
(DIR)
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2000
Total Cost
Indirect Cost
Name
U.S. National Eye Institute
Department
Type
DUNS #
City
State
Country
United States
Zip Code
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