NCT00050492

Brief 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 Upon entering the study, participants will have about 10 teaspoons of blood withdrawn from an arm vein through a needle and again 6 months and 12 months later.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2002

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2006

Completed
Last Updated

July 2, 2017

Status Verified

September 19, 2006

First QC Date

December 9, 2002

Last Update Submit

June 30, 2017

Conditions

Keywords

OcularCytokineChemokineVirusesAutoantibodyRetinaVasculitisAdhesion Molecules

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are under the age of 10 or who are pregnant will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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. doi: 10.1084/jem.184.2.387.

    PMID: 8760792BACKGROUND

MeSH Terms

Conditions

Retinal VasculitisVirus DiseasesVasculitis

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVascular DiseasesCardiovascular DiseasesInfections

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 9, 2002

First Posted

December 10, 2002

Study Start

December 6, 2002

Study Completion

September 19, 2006

Last Updated

July 2, 2017

Record last verified: 2006-09-19

Locations