Daclizumab Injections to Treat Non-Infectious Sight-Threatening Uveitis
Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
Participant gender:
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 evaluations may be spread out to every 3 or 4 weeks. Over time, fewer tests
may be required during the biweekly examinations if the patient is doing well, but nearly all
the examinations done at screening will be repeated at 3-month intervals. If inflammation or
vision loss occurs during drug tapering, appropriate treatment will be administered. If the
vision loss is too great, the patient will be treated with steroids or other medicines and
taken off the study.
Additional, special tests done at selected study centers include the following:
- Fluorescein angiography: This test is done to check for abnormalities of eye blood
vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in
the eyes. Pictures of the retina are taken with a special camera that flashes a blue
light into the eye. The pictures show if any dye has leaked from the vessels into the
retina, indicating possible abnormalities.
- Pelvic ultrasound and urine test: These tests are done at enrollment and after 1 year to
check the kidneys, lymph nodes, and pelvic area.
- Blood tests: Additional blood tests are done at enrollment and every 3 to 6 months for
laboratory and immunology study.