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K. J. Wroblewski, H. Sen, L. Faia, S. Yeh, R. B. Nussenblatt, J. Ragheb; Combination Daclizumab/Sirolimus Therapy for the Induction of Immune Tolerance in Non-Infectious Intermediate and Posterior Uveitis. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2025.
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To investigate the efficacy of Daclizumab and Sirolimus to induce peripheral immune tolerance in non-infectious intermediate and posterior uveitis. This was an open-label Phase II pilot trial conducted at the National Eye Institute.
A total of six participants who were already on Daclizumab monotheraphy were enrolled. Participant 1 terminated from the study due to a decrease in visual acuity and surgery. A 6mg loading dose of oral Sirolimus was started at Week 0, followed by 2mg every other day for two weeks. If tolerated, it was given at a dosage of 2mg daily in combination with Daclizumab for one year and then Daclizumab followed by the Sirolimus was tapered off. The primary outcome was vitreous haze less than trace for 24 weeks after completion of the taper at approximately Study Week 134 while receiving no other concomitant systemic immunosuppressive medications.
Four patients out of five met the primary end point and had no flares free of all immunosuppressive medications by week 134. One patient required aggressive topical corticosteroids and then reintroduction of Daclizumab to control her intraocular inflammation and one other patient met the final outcome but required a periocular injection to control a disease flare. Six months after study closure, 3 out of five patients continue to be quiet off all immunosuppressive medications.
Clinical Trial: :
www.clinicaltrials.gov NEI 04-EI-0115
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