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The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00331331
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : July 8, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Brief 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.

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 or disease
Uveitis Vasculitis Ocular Inflammatory Disease

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. Specimens of anterior chamber fluid and 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. Previously, patients 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, were enrolled. However, as the MUST study is complete; we are currently only accepting participants from the NEI or other intramural NIH studies where permission is obtained from the patient to allow such evaluations to be done.

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Study Type : Observational
Actual Enrollment : 147 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Study Start Date : May 19, 2006

Resource links provided by the National Library of Medicine

Participants that permits the evaluation of specimens.

Primary Outcome Measures :
  1. Kinds of cytokines/lymphokines, biomarkers, proteome and exosomes present in vitreous and AC fluid in eye with uveitis or other retinal disorders. [ Time Frame: Ongoing ]
    To gather information about the kinds of cytokines/lymphokines present in the vitreous and anterior chamber fluid of an eye with uveitis or other retinal disorders.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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. Listed below are the inclusion and exclusion criteria.

Participants must participate in a study that permits the evaluation of specimens.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00331331

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
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Principal Investigator: Hatice N Sen, M.D. National Eye Institute (NEI)
Additional Information:
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Responsible Party: National Eye Institute (NEI) Identifier: NCT00331331    
Other Study ID Numbers: 060068
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: September 26, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Intermediate Uveitis
Macular Edema
Additional relevant MeSH terms:
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Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases