Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ) Identifier:
First received: May 27, 2006
Last updated: April 20, 2017
Last verified: October 26, 2016

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.

Ocular Inflammatory Disease

Study Type: Observational
Official Title: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

Resource links provided by NLM:

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

Enrollment: 70
Study Start Date: May 19, 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. 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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00331331

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
Principal Investigator: Hatice N Sen, M.D. National Eye Institute (NEI)
  More Information

Additional Information:
Responsible Party: National Eye Institute (NEI) Identifier: NCT00331331     History of Changes
Other Study ID Numbers: 060068
Study First Received: May 27, 2006
Last Updated: April 20, 2017

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

Additional relevant MeSH terms:
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 25, 2017