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NCT00280826 · ClinicalTrials.gov registry record · Phase 1
Efalizumab to Treat Uveitis
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00280826 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 6 participants.
The verdict
NCT00280826, 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 examined the safety and potential efficacy of the monoclonal antibody efalizumab (Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the activity of white blood cells called lymphocytes that cause inflammation. The drug is currently approved in the United States to treat patients with moderate to severe psoriasis. Participants 18 and older with sight-threatening intermediate or posterior uveitis of at least 3 months duration, causing persistent macular edema in one or both eyes, were eligible for this study. The uveitis required treatment with at least 20 milligrams per day of prednisone, or the equivalent, or a combination of two or more anti-inflammatory treatments such as prednisone, methotrexate, cyclophosphamide, cyclosporine, etc. Participants underwent the following tests and procedures: * Medical history and physical examination. * Weekly efalizumab treatment. * Weekly eye examination, including measurement of vision and pressure in the eyes, dilation of the eyes and examination of the front and back parts of the eye. * Weekly blood tests to measure the number and types of cells in the blood and to check for signs of inflammation and treatment side effects. At some visits, blood samples were collected to measure how much efalizumab remains in the blood and whether the body has developed an immune response to the medicine. * Blood draw at enrollment and at 2 and 4 months for research tests to examine how participants' immune response was operating. * Fluorescein angiography at enrollment and 1 and 3 months after enrollment, unless additional tests are needed, for medical management. This test checked for abnormalities of eye blood vessels. A yellow dye was injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina (the back portion of the eye) were taken with a special camera that flashes a blue light into the eye. The pictures show whether any dye has leaked from the vesse
Interventions
- DRUG Efalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-01 |
| Est. Completion | 2009-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00280826
The ClinicalTrials.gov registry entry for NCT00280826 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 Efalizumab is the first listed.
NCT00280826 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00280826 about?
NCT00280826 is a clinical study titled "Efalizumab to Treat Uveitis". This study examined the safety and potential efficacy of the monoclonal antibody efalizumab (Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the activity of white blood cells called lymphocytes that cause inflammation. The drug is currently approved in the Uni...
What is the current status of trial NCT00280826?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2006-01. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00280826?
The interventions under investigation include: Efalizumab (DRUG).
Who is sponsoring clinical trial NCT00280826?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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