Combination Daclizumab/Sirolimus Therapy For the Induction of Immune Tolerance in Non-Infectious Intermediate and Posterior Uveitis
Data Collection
Eye Diseases
+ Uveal Diseases
+ Uveitis
Treatment Study
Summary
Study start date: March 3, 2004
Actual date on which the first participant was enrolled.We propose to investigate the possible efficacy of combination daclizumab and sirolimus 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 on daclizumab monotherapy will receive a 6 mg loading dose of oral sirolimus at week 0, followed by a 2 mg dose every other day for 2 weeks. If tolerated, the subject will be increased to a 2 mg daily dose. After one year of combination therapy, the subject will be tapered off daclizumab first and then sirolimus. The primary outcome will be the ability of the participant to be successfully tapered off daclizumab and sirolimus while their disease remains quiet (vitreous haze less than or equal to Trace) for 24 weeks on no systemic immunosuppressive medications (approximately week 134).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
* INCLUSION CRITERIA: Participant is 18 years of age or older. Participant with uveitis in one or both eyes on daclizumab monotherapy without disease flare in the past 6 months. Participant agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of treatment with daclizumab or sirolimus. Participant is able to understand and sign a consent form before entering the study. EXCLUSION CRITERIA: Participant with a history of hypersensitivity to FK506 or sirolimus. Participant who has had major surgery in the past 6 months. Participant is pregnant or lactating. Participant with active chronic or acute infections. Participant with malignancy other than squamous cell carcinoma in situ. Participant with uncontrolled hyperlipidemia at the time of enrollment. Participant without VZV antibodies. Participant without Hepatitis antibodies (anti-HAV or anti-HBc) AND with any one of the following risk factors for acquiring hepatitis: IV drug abuse, male homosexual activity, hemophilia, prostitution, or health care work. Participant requiring systemic anti-fungal therapy with ketoconazole for whom no other acceptable alternative anti-fungal therapy exists.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesSee the location