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Sponsor study identifier
Secondary identifiers
observational
147
1 country
1
Study Start
February 14, 2007
Actual (reported)Primary Completion
February 1, 2019
Actual (reported)Study Completion
February 1, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 27, 2006
Actual (reported)May 29, 2006
Actual (reported)February 14, 2007
Actual (reported)February 1, 2019
Actual (reported)February 1, 2019
Actual (reported)To compare the vitreous and anterior chamber fluid immune/protein profile with that of the peripheral blood.
To compare the vitreous and anterior chamber fluid immune/protein profile with that of the peripheral blood.
duration of the study
To begin to develop a proteomic picture of the vitreous and anterior chamber fluid.
To begin to develop a proteomic picture of the vitreous and anterior chamber fluid.
duration of study
To gather information about the kinds of cytokines/lymphokines, biomarkers, proteome and exosomes that are present in the vitreous and AC fluid of an eye with uveitis as well as other retinal disorders such as AMD, diabetes and others.
To gather information about the kinds of cytokines/lymphokines, biomarkers, proteome and exosomes that are present in the vitreous and AC fluid of an eye with uveitis as well as other retinal disorders such as AMD, diabetes and others.
Participants with appropriate ocular disorders who were previously enrolled as part of the MUST study and patients who participate in other intramural NIH studies
Up to 300 participants will be enrolled in the study. This number includes participants that were previously enrolled as part of the MUST study, as well as patients who participate in other intramural NIH studies and agree to participate in this study. The MUST study collection has been completed and this study is open to all qualifying participants.
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Vitreous, anterior chamber fluid, whole blood
Emily Y Chew, M.D.
National Eye Institute (NEI)
147 participants (actual enrollment reported by the registry).
First Submitted
May 27, 2006
First Posted
May 29, 2006
Study Start
February 14, 2007
Actual (reported)duration of the study
Contact the study team to confirm eligibility.
Primary Completion
February 1, 2019
Actual (reported)Study Completion
February 1, 2019
Actual (reported)Last Updated
October 30, 2024
Record last verified: 2024-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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