Status:
COMPLETED
Daclizumab and Sirolimus to Treat Uveitis
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will examine whether the combination of the drugs daclizumab and sirolimus can effectively treat adults with uveitis, an eye inflammation. Daclizumab is a monoclonal antibody that is design...
Detailed Description
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 po...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 3 2004
Trial Type :
INTERVENTIONAL
End Date :
July 18 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00078689
Start Date
March 3 2004
End Date
July 18 2008
Last Update
July 2 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892