A Phase 2 interventional study of Daclizumab in Non-infectious Intermediate and Posterior Uveitis, sponsored by National Eye Institute (NEI). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by National Eye Institute (NEI) · Phase 2, Interventional, and Treatment
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:
We propose to investigate the possible efficacy of combination daclizumab and denileukin diftitox therapy to induce peripheral immune tolerance in participants presenting with non-infectious intermediate and posterior uveitis. This will be performed using a Phase I/II pilot study. Subjects whose disease is controlled on daclizumab therapy will have their daclizumab-dosing interval progressively increased by one-week increments. If and when they experience signs or symptoms of an ocular flare, they will be treated with denileukin diftitox, 24 hours after which they will receive their usual dose of daclizumab. Participants may receive up to 12 such cycles of daclizumab/denileukin diftitox therapy. When the daclizumab-dosing interval is 10 weeks long or less than 10% of their CD4 T cell CD25 is occupied by daclizumab, therapy will be discontinued. Following discontinuation of daclizumab patients will be followed for recurrence of ocular disease. Failure to reach this study point after 12 cycles or disease recurrence following discontinuation of therapy will constitute a study failure. The primary outcome will be the ability of the participant to be successfully tapered off daclizumab while their disease remains quiet (vitreous haze less than or equal to Trace) at week 104 while receiving no concomitant systemic immunosuppressive medications.
To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria.
EXCLUSION CRITERIA:
To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria.
This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.
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National Eye Institute (NEI)