Daclizumab Injections to Treat Non-Infectious Sight-Threatening Uveitis

Study Summary

This study will examine the safety and effectiveness of a monoclonal antibody called daclizumab in treating uveitis, an eye inflammation. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. Daclizumab is designed to prevent a specific chemical interaction needed for immune cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10 adults with uveitis, 8 patients were able to decrease corticosteroids and other immunosuppressive medicines they were taking while receiving daclizumab for months or even years. The study will be conducted at three different sites, including the NIH Clinical Center. Patients 6 years of age and older with non-infectious uveitis of at least 3 months' duration who require treatment with immune suppressing medicines, such as prednisone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, or others, may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, complete eye examination, and a questionnaire about the patient's vision and daily activities. Participants will come to the study center every 2 weeks for treatment and evaluation. Daclizumab treatments are given by injection under the skin, usually in the arm. Patients will receive a maximum of 28 treatments over a 1-year period. Treatment may be extended for a few months while other participants reach their 1-year mark. The first two induction treatments are at a higher dose (2 mg/kg of body weight) than the maintenance dose of 1 mg/kg. After the first daclizumab treatment, other uveitis medications will be tapered, one at a time. If the disease remains quiet, these drugs may eventually be stopped completely. For the first 6 months, all patients will receive daclizumab injections and evaluations every 2 weeks. After that, if other medications have been reduced and vision has remained stable, treatments and evaluat

Interventions

• DRUG Daclizumab