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NCT00331331 · ClinicalTrials.gov registry record
The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
A clinical trial, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- 147
- Enrollment target
NCT00331331: Completed study, sponsored by National Eye Institute (NEI).
NCT00331331 is a clinical trial that has completed, run by National Eye Institute (NEI). The registered enrollment target is 147 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00331331 has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- 147 participants
- Enrollment target
Study Summary
This study will examine the proteins of people with uveitis, or inflammation of the eyes. Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back of the lens, is now possible with the use of new microtechnology. There is an opportunity to evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening uveitis. Up to 300 participants, ages 18 and older with the appropriate ocular disorders and where vitreous or anterior chamber fluid specimens can be obtained, will be enrolled in the study. This number includes participants that were previously enrolled as part of the Multicenter Uveitis Steroid Treatment (MUST) study, as well as patients who participate in other intramural NIH studies and agree to participate in this study. Researchers will study the vitreous that will be removed from patients' eyes during an operation to insert a steroid implant. The steroid implant is used instead of immunosuppressive therapy, a way to reduce the action of the immune system. Patients will undergo a procedure involving a small hole made in the eye into which the implant is placed. Normally a small amount of the vitreous comes out during that procedure, and in this study, the vitreous specimen will be taken for testing of inflammatory products. At the same time, a small sample of blood, about 1-1/2 tablespoons, will be collected so that the researchers can compare inflammatory products that may be in the blood with those in the vitreous. If a patient needs to have the implant placed again during the study, he or she would be asked permission for collection of the vitreous and blood samples, as previously. Samples collected will not be used to diagnose patients' conditions or to change any treatments being done. All samples will be labeled with special code numbers so that there is no identifying information about patients. This study will not involve examinations or scheduled visits of patients.
Primary Outcome
To compare the vitreous and anterior chamber fluid immune/protein profile with that of the peripheral blood.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2007-02-14 |
| Est. Completion | 2019-02-01 |
What the finished NCT00331331 record still lists
NCT00331331 is an observational study that tracks outcomes without assigning an intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00331331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00331331 about?
NCT00331331 is a clinical study titled "The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease". This study will examine the proteins of people with uveitis, or inflammation of the eyes. Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back of the lens, is now possible with the use of new microtechnology. There is an opportunity to evaluate the kinds of pro...
What is the current status of trial NCT00331331?
This trial is currently completed. The enrollment target is 147 participants. The study started on 2007-02-14. Estimated completion is 2019-02-01.
Who is sponsoring clinical trial NCT00331331?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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