Status:
COMPLETED
Combination Daclizumab/Denileukin Diftitox to Treat Uveitis
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Non-infectious Intermediate and Posterior Uveitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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....
Detailed Description
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 intermedi...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria.
- Participant is 18 years of age or older. (The vast majority of T cells are produced before adulthood and the long-term consequences of inducing immune tolerance are unknown, it would thus seem prudent to exclude juveniles from the study.)
- Participant with uveitis in one or both eyes on daclizumab therapy without disease flare in the past 6 months.
- Participants of reproductive age agree 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 must be willing and prepared to travel to NIH on short notice for treatment and to be hospitalized if deemed medically necessary.
- Participant is able to understand and sign a consent form before entering the study.
- EXCLUSION CRITERIA:
- To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria.
- Participant with a history of hypersensitivity to denileukin diftitox.
- Participant is pregnant or lactating.
- Participant with active chronic or acute infections.
- Participant with a history of cardiovascular disease, significant respiratory disease, coagulation disorders, or other major medical illnesses that may limit their ability to tolerate the toxicities associated with denileukin diftitox.
- Participant with a serum albumin less than 3.0.
- Participant with malignancy other than squamous cell carcinoma in situ.
Exclusion
Key Trial Info
Start Date :
May 11 2006
Trial Type :
INTERVENTIONAL
End Date :
December 20 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00326508
Start Date
May 11 2006
End Date
December 20 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892