The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

NCT00331331 | Completed

• 2 other identifiers: 06006806-EI-0068
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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. Up to 300 participants, ages 18 and older with the appropriate ocular disorders and where vitreous or anterior chamber fluid specimens can be obtained, will be enrolled in the study. This number includes participants that were previously enrolled as part of the Multicenter Uveitis Steroid Treatment (MUST) study, as well as patients who participate in other intramural NIH studies and agree to participate in this study. 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.

Conditions

Uveitis; Vasculitis; Ocular Inflammatory Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• To compare the vitreous and anterior chamber fluid immune/protein profile with that of the peripheral blood.

  To compare the vitreous and anterior chamber fluid immune/protein profile with that of the peripheral blood.

  duration of the study

• To begin to develop a proteomic picture of the vitreous and anterior chamber fluid.

  To begin to develop a proteomic picture of the vitreous and anterior chamber fluid.

  duration of study

• To gather information about the kinds of cytokines/lymphokines, biomarkers, proteome and exosomes that are present in the vitreous and AC fluid of an eye with uveitis as well as other retinal disorders such as AMD, diabetes and others.

  To gather information about the kinds of cytokines/lymphokines, biomarkers, proteome and exosomes that are present in the vitreous and AC fluid of an eye with uveitis as well as other retinal disorders such as AMD, diabetes and others.

  duration of the study

Study Arms (1)

Patients

Participants with appropriate ocular disorders who were previously enrolled as part of the MUST study and patients who participate in other intramural NIH studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

Vitreous, anterior chamber fluid, whole blood

MeSH Terms

Conditions

Uveitis; Vasculitis; Uveitis, Intermediate; Macular Edema

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Study Officials

• Emily Y Chew, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2006
• First Posted: May 29, 2006
• Study Start: February 14, 2007
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)