The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

Uveitis Clinical Trial

Official title:

The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331331
• Other study ID #: 060068
• Secondary ID: 06-EI-0068
• Status: Completed
• Start date: February 14, 2007

Study information

• Verified date: June 6, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

Participants 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.

Related Conditions & MeSH terms

• Ocular Inflammatory Disease
• Uveitis
• Vasculitis

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinds of cytokines/lymphokines, biomarkers, proteome and exosomes present in vitreous and AC fluid in eye with uveitis or other retinal disorders.	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.	duration of the study

External Links

•   NIH Clinical Center Detailed Web Page