NIH Clinical Research Studies

Protocol Number: 03-EI-0068

Active Accrual, Protocols Recruiting New Patients

Title:
Identification of Biological Markers in Retinal Vasculitis
Number:
03-EI-0068
Summary:
This study will look for biological markers of primary retinal vasculitis that can be useful in understanding what causes the disease. It will evaluate its progression, and develop and monitor treatments. Biological markers are substances (e.g., chemicals called cytokines and chemokines or antibodies) that are associated with a disease or condition such as retinal vasculitis. Retinal vasculitis is an inflammation of blood vessels in the retina that can cause retinal damage and subsequent loss of vision. It can occur by itself (primary retinal vasculitis), or it can be part of a systemic vascular disease.

The study will evaluate patients with primary retinal vasculitis and compare the findings with those of two other groups of patients with retinal vasculitis patients with Behcet's syndrome and HIV-infected patients undergoing HAART therapy.

Patients over 10 years of age with sight-threatening retinal vasculitis may be eligible for this study. (page 6 of the protocol, under #4 Study Design and Methods, says the age range is 2 years old and above; page 10, under #5 Participant Inclusion and Exclusion Criteria, says initial enrollment will include all patients over the age of 10 years).

Upon entering the study, participants will have about 10 teaspoons of blood withdrawn from an arm vein through a needle and again 6 months and 12 months later. The blood samples will be analyzed for cytokines, chemokines or adhesion molecules, certain types of antibodies, and infectious agents.

Sponsoring Institute:
National Eye Institute (NEI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Initial enrollment would include all patients over the age of 2 years with sight threatening retinal vasculitis. Patients will be identified with progressive disease and those with stable disease.

EXCLUSION CRITERIA:

Patients who are under the age of 2 or who are pregnant will be excluded from the study.

Special Instructions: Currently Not Provided
Keywords:
Ocular
Cytokine
Chemokine
Viruses
Autoantibody
Retina
Vasculitis
Adhesion Molecules
Recruitment Keywords:
None
Conditions:
Retinal Vasculitis
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE,et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. PMID: 7526212

Archelos JJ, Hartung HP. Pathogenetic role of autoantibodies in neurological diseases. Trends Neurosci. 2000 Jul;23(7):317-27. Review. PMID: 10856942

Asano M, Toda M, Sakaguchi N, Sakaguchi S. Autoimmune disease as a consequence of developmental abnormality of a T cell subpopulation. J Exp Med. 1996 Aug 1;184(2):387-96. PMID: 8760792

Active Accrual, Protocols Recruiting New Patients

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