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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00331331 |
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.
Patients ages 18 and older who have been enrolled in the Multicenter Uveitis Steroid Treatment (MUST) study at NIH may be eligible for this study. Up to 200 patients eventually may be enrolled. 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.
Condition |
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Uveitis Vasculitis Ocular Inflammatory Disease |
Study Type: | Observational |
Official Title: | The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease |
Estimated Enrollment: | 300 |
Study Start Date: | May 2006 |
Newer therapies to treat many ocular disorders including uveitis are being considered and studied. We do not have a clear picture as to what lymphokines/chemokines are present in the vitreous or anterior chamber fluid of patients with active intraocular inflammatory disease as well as other disorders with a proposed inflammatory component such as age related macular degeneration (AMD) and diabetes. Further, no studies have been yet performed evaluating the proteome of the vitreous or anterior chamber fluid in the uveitic, AMD and diabetic state.
This is a natural history study with specimens taken after indicated surgery for patients with uveitis and other studies. Eligible patients will include those participating in the MUST (Multicenter Uveitis Steroid Treatment) study, a randomized study evaluating an ocular steroid implant versus standard immunosuppressive therapy for the treatment of intermediate and posterior uveitis. The NIH Clinical Center will be one of these sites. Other MUST study site patients will be eligible to participate as well in the future if their respective IRBs approve this protocol as well as the MUST Steering Committee. Specimens of vitreous will be evaluated for 32 cytokines and the proteome using systems permitting the evaluation of small amounts of material. A serum sample will be taken at the same time to compare with the lymphokine profile found in the vitreous.
In addition to the MUST study, we will accept vitreous or anterior chamber fluid with serum samples from other intramural NIH studies where permission is obtained from the patient to allow such evaluations to be done. Both anterior chamber fluid and vitreous samples will undergo same cytokine and proteome evaluation. For extramural sites outside of MUST, we will ask that they submit this protocol for review and acceptance by their local IRB.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients meet the criteria for entry into the MUST study and have been randomized to receive a steroid implant.
Those who are in other studies must participate in a study that permits the evaluation of specimens.
EXCLUSION CRITERIA:
Eligible participants who do not wish to donate their vitreous specimen or anterior chamber fluid, as appropriate, or blood sample or undergo a blood draw for the purposes of this research study.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
University of Southern California Health Sciences Campus | Recruiting |
Los Angeles, California, United States, 90033 | |
United States, Florida | |
University of Southern Florida | Recruiting |
Tampa, Florida, United States | |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30322-1102 | |
United States, Illinois | |
Rush Presbyterian St. Luke's Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
United States, Massachusetts | |
Massachusetts Eye Research and Surgery Institute | Recruiting |
Cambridge, Massachusetts, United States | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-0624 | |
United States, Missouri | |
Washington University, St. Louis | Recruiting |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
New York Eye & Ear Infirmary | Recruiting |
New York, New York, United States | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-6056 | |
United States, Texas | |
Vitreoretinal Consultants/Methodist Hospital | Recruiting |
Houston, Texas, United States | |
United States, Utah | |
University of Utah | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
United States, Virginia | |
George Mason University | Recruiting |
Fairfax, Virginia, United States, 22030 |
Study ID Numbers: | 060068, 06-EI-0068 |
Study First Received: | May 27, 2006 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00331331 |
Health Authority: | United States: Federal Government |
Uveitis Intermediate Uveitis Pars Planitis Macular Edema |
Vasculitis Uveitis Ocular Inflammatory Disease |
Macular Edema Vasculitis Uveitis, Intermediate Uveitis |
Eye Diseases Vascular Diseases Edema |
Uveal Diseases Cardiovascular Diseases |