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Protocol Details

The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

06-EI-0068

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

Uveitis;
Intermediate Uveitis;
OCULAR INFLAMMATORY DISEASE;
Macular Edema;
Vasculitis;
Natural History

Recruitment Keyword(s)

Uveitis;
Ocular Inflammatory Disease

Condition(s)

Uveitis;
Vasculitis;
Ocular Inflammatory Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Eye Institute

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.

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Emily Y. Chew, M.D.
National Eye Institute (NEI)
NIHBC 10 - CRC BG RM 3-2531
10 CENTER DR
BETHESDA MD 20892
(301) 496-6583
echew@nei.nih.gov

Patti Sherry, C.R.N.O.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 435-4529
patti.sherry@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00331331

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