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NCT00043667 · ClinicalTrials.gov registry record · Phase 2
Daclizumab Injections to Treat Non-Infectious Sight-Threatening Uveitis
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00043667 is a Phase 2 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 15 participants.
The verdict
NCT00043667, a Phase 2 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of a monoclonal antibody called daclizumab in treating uveitis, an eye inflammation. 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. The study will be conducted at three different sites, including the NIH Clinical Center. Patients 6 years of age and older with non-infectious uveitis of at least 3 months' duration who require treatment with immune suppressing medicines, such as prednisone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, or others, may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, complete eye examination, and a questionnaire about the patient's vision and daily activities. Participants will come to the study center every 2 weeks for treatment and evaluation. Daclizumab treatments are given by injection under the skin, usually in the arm. Patients will receive a maximum of 28 treatments over a 1-year period. Treatment may be extended for a few months while other participants reach their 1-year mark. The first two induction treatments are at a higher dose (2 mg/kg of body weight) than the maintenance dose of 1 mg/kg. After the first daclizumab treatment, other uveitis medications will be tapered, one at a time. If the disease remains quiet, these drugs may eventually be stopped completely. For the first 6 months, all patients will receive daclizumab injections and evaluations every 2 weeks. After that, if other medications have been reduced and vision has remained stable, treatments and evaluat
Interventions
- DRUG Daclizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2002-08 |
| Est. Completion | 2004-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00043667
The ClinicalTrials.gov registry entry for NCT00043667 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 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.
NCT00043667 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00043667 about?
NCT00043667 is a clinical study titled "Daclizumab Injections to Treat Non-Infectious Sight-Threatening Uveitis". This study will examine the safety and effectiveness of a monoclonal antibody called daclizumab in treating uveitis, an eye inflammation. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. Daclizumab is designed to p...
What is the current status of trial NCT00043667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2002-08. Estimated completion is 2004-10.
What interventions are being tested in trial NCT00043667?
The interventions under investigation include: Daclizumab (DRUG).
Who is sponsoring clinical trial NCT00043667?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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