Biological Markers in Retinal Vasculitis
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Retinal Vasculitis
Phase: N/A
Status: Completed
Sponsored by: National Eye Institute (NEI)
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Upon entering the study, participants will have about 10 teaspoons of blood withdrawn from an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.
Clinical Details
Official title: Identification of Biological Markers in Retinal Vasculitis
Study design: N/A
Detailed description:
Retinal vasculitis is a major component of ocular inflammation that plays a critical role in
retinal tissue damage and subsequent vision loss. Retinal vasculitis can occur as a primary
ocular disease or secondarily, as a component of a systemic vascular disease. Unfortunately,
little is known about primary retinal vasculitis. The initiating event in retinal vasculitis
is most likely multifactorial. Nevertheless, the underlying pathologic mechanisms driving
this process may be common. We hypothesize that there are biological markers of retinal
vasculitis, such as, cytokines, chemokines, adhesion molecules, T-cell surface markers and
autoantibodies which can be useful in determining disease progression, understanding
mechanisms of pathogenesis, identifying therapeutic strategies and monitoring treatments.
The purpose or objective of this study is to investigate selected biological markers to
collect clinical and biologic information to better understand the natural history of
conditions indicative of primary retinal vasculitis.
The goal of this study is to evaluate patients with primary retinal vasculitis disorders. We
will compare this group of patients with two additional types of uveitis patients with
retinal vasculitis; patients with Behcet's syndrome and HIV patients undergoing HAART therapy
with immune recovery uveitis. Patient evaluations will consist of the following procedures:
a full ocular examination, fluorescent angiogram study, blood collection and therapy.
Patient blood samples will be studied to evaluate the presence of three types of biological
markers (1) cytokines, chemokines or adhesion molecules, (2) autoantibodies and (3)
infectious agents. The primary outcome of this study is the identification of biological
markers in patients with retinal vasculitis.
Eligibility
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
- INCLUSION CRITERIA:
Initial enrollment would include all patients over the age of 10 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 10 or who are pregnant will be excluded from the study.
Locations and Contacts
National Eye Institute (NEI), Bethesda, Maryland 20892, United States
Additional Information
Related publications: 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.
Starting date: December 2002
Ending date: September 2006
Last updated: March 5, 2008
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