Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis
Status:
Completed
Trial end date:
2006-10-02
Target enrollment:
Participant gender:
Summary
This study will examine the safety and effectiveness of treating uveitis, an eye
inflammation, with a monoclonal antibody called daclizumab. 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. Seven patients continue to take the drug.
Patients 18 years of age and older with active non-infectious intermediate or posterior
uveitis in both eyes who require treatment for their disease may be eligible for this study.
Candidates will be screened with the following tests and procedures:
- Medical history and physical examination.
- Eye examination to measure visual acuity and eye pressure, and examine the lens, retina,
pupils and eye movements.
- Blood tests to measure the number and types of blood cells.
- Fluorescein angiography to check for abnormalities of eye blood vessels. A yellow dye
injected into an arm vein 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.
Participants come to the NIH Clinical Center for treatment and follow-up visits. The first
daclizumab treatment is given as a 90-minute infusion through a vein. A second IV infusion is
given 7 days later. If the treatment has successfully reduced the eye inflammation after 2
weeks, then subsequent treatments are given through injections under the skin once a month
for up to 1 year. Patients whose eye disease is not improved after 2 weeks stop the study
treatments and receive alternative therapy.
Follow-up visits are scheduled 7, 14, and 21 days after enrollment and at each treatment
visit to evaluate the response to treatment and drug side effects. During these visits,
patients repeat the exams done at screening. Extra blood samples are taken at certain visits
to measure blood levels of daclizumab and to perform clinical laboratory and immunology
tests. Fluorescein angiography is done at enrollment and after 1 year.