Combination Daclizumab/Denileukin Diftitox to Treat Uveitis
Status:
Completed
Trial end date:
2006-12-20
Target enrollment:
Participant gender:
Summary
This study will determine whether treatment with a combination of the drugs daclizumab and
denileukin diftitox can eliminate the need for long-term daclizumab treatment in adult
patients with uveitis. Denileukin diftitox kills white blood cells called lymphocytes that
cause inflammation and may be the cause of uveitis.
Patients 18 years of age and older with uveitis in one or both eyes who are on daclizumab
therapy and have not had a disease flareup in 6 months may be eligible for this study.
Candidates are screened with a medical history, physical examination, eye examination
(including vision test, examination of the front of the eye, and pupil dilation for
examination of the retina at the back of the eye), blood tests and a questionnaire about
their vision and daily activities.
After screening, participants undergo the following procedures:
- Daclizumab/ denileukin diftitox treatment. Patients receive their regular dose of
daclizumab intravenously (through a vein). The interval between doses is increased by 1
week after each dose. When the doses are 10 weeks apart, the daclizumab is stopped.
Patients who experience a flare or uveitis are treated with intravenous denileukin
diftitox and possibly local injections of steroids around the eye or increasing or
adding other medicines as needed to control the uveitis.
- Fluorescein angiography to look for blood vessel abnormalities in the eyes. A yellow dye
is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of
the retina (the back portion of the eye) 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.
- Ultrasound and urine tests at enrollment and after 1 year to check kidneys, lymph nodes
and pelvic area.
- Blood tests at enrollment and every 3-6 months for laboratory and immunology tests and
other research tests on blood cells to examine the immune response.
- Follow-up visits approximately every 6 weeks for 2 years for repeat examinations to
determine the response to treatment and drug side effects.
Phase:
Phase 2
Details
Lead Sponsor:
National Eye Institute (NEI)
Treatments:
Daclizumab Denileukin diftitox Immunoglobulin G Interleukin-2