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The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), November 2008
Sponsored by: National Eye Institute (NEI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00331331
  Purpose

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
Uveitis
Vasculitis
Ocular Inflammatory Disease

MedlinePlus related topics: Vasculitis
U.S. FDA Resources
Study Type: Observational
Official Title: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 300
Study Start Date: May 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331331

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
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
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Institutes of Health Clinical Center (CC):
Uveitis
Intermediate Uveitis
Pars Planitis
Macular Edema
Vasculitis
Uveitis
Ocular Inflammatory Disease

Study placed in the following topic categories:
Macular Edema
Vasculitis
Uveitis, Intermediate
Uveitis
Eye Diseases
Vascular Diseases
Edema

Additional relevant MeSH terms:
Uveal Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009