Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00078689 · ClinicalTrials.gov registry record · Phase 1
Daclizumab and Sirolimus to Treat Uveitis
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00078689 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 6 participants.
The verdict
NCT00078689, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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 designed to prevent a specific chemical interaction needed for immune cells called lymphocytes to produce inflammation. Sirolimus is an immune-suppressing drug that also controls lymphocyte activity and is marketed to prevent organ rejection in kidney transplants. Patients 18 years of age and older with non-infectious uveitis in one or both eyes who are being treated with daclizumab and have not had a relapse or disease flare for 6 months before entering this trial may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, complete eye examination, and pregnancy test for women who can have children. Women of child-bearing potential who enroll in this study will have a pregnancy test every 12 weeks. After enrollment, participants have the following additional exams: * Fluorescein angiography: This test is done to check for abnormalities of eye blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina 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. This test is done at enrollment and after 1 year, unless additional tests are needed for medical management. * Pelvic ultrasound and urine test: These tests are done at enrollment and after 1 year to check the kidneys, lymph nodes, and pelvic area. * Blood tests: Blood tests are done at enrollment and every 3 to 6 months for laboratory and immunology study Patients receive daclizumab subcutaneously (under the skin) or in infusions at regularly scheduled visits for 52 weeks. At each treatment, blood pressure, pulse, breathing rate, and temperature are monitored. After the fir
Interventions
- DRUG Daclizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2004-03-03 |
| Est. Completion | 2008-07-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078689
The ClinicalTrials.gov registry entry for NCT00078689 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Daclizumab is the first listed.
NCT00078689 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00078689 about?
NCT00078689 is a clinical study titled "Daclizumab and Sirolimus to Treat Uveitis". 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 designed to prevent a specific chemical interaction needed for immune cells called lymphocytes to produce ...
What is the current status of trial NCT00078689?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2004-03-03. Estimated completion is 2008-07-18.
What interventions are being tested in trial NCT00078689?
The interventions under investigation include: Daclizumab (DRUG).
Who is sponsoring clinical trial NCT00078689?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.