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NCT00070759 · ClinicalTrials.gov registry record · Phase 2
Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00070759 is a Phase 2 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 6 participants.
The verdict
NCT00070759, a Phase 2 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of treating uveitis, an eye inflammation, with a monoclonal antibody called daclizumab. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. Daclizumab is designed to prevent a specific chemical interaction needed for immune cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10 adults with uveitis, 8 patients were able to decrease corticosteroids and other immunosuppressive medicines they were taking while receiving daclizumab for months or even years. Seven patients continue to take the drug. Patients 18 years of age and older with active non-infectious intermediate or posterior uveitis in both eyes who require treatment for their disease may be eligible for this study. Candidates will be screened with the following tests and procedures: * Medical history and physical examination. * Eye examination to measure visual acuity and eye pressure, and examine the lens, retina, pupils and eye movements. * Blood tests to measure the number and types of blood cells. * Fluorescein angiography to check for abnormalities of eye blood vessels. A yellow dye injected into an arm vein 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. Participants come to the NIH Clinical Center for treatment and follow-up visits. The first daclizumab treatment is given as a 90-minute infusion through a vein. A second IV infusion is given 7 days later. If the treatment has successfully reduced the eye inflammation after 2 weeks, then subsequent treatments are given through injections under the skin once a month for up to 1 year. Patients whose eye disease is not improved after 2 weeks stop the study treatments and receive alternative therapy. Fo
Interventions
- DRUG Daclizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2003-10-06 |
| Est. Completion | 2006-10-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00070759
The ClinicalTrials.gov registry entry for NCT00070759 describes a study currently listed as completed, categorized as Phase 2. 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.
NCT00070759 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00070759 about?
NCT00070759 is a clinical study titled "Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis". This study will examine the safety and effectiveness of treating uveitis, an eye inflammation, with a monoclonal antibody called daclizumab. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. Daclizumab is designed t...
What is the current status of trial NCT00070759?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2003-10-06. Estimated completion is 2006-10-02.
What interventions are being tested in trial NCT00070759?
The interventions under investigation include: Daclizumab (DRUG).
Who is sponsoring clinical trial NCT00070759?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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