Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases
Primary Purpose
Eye Diseases
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Eye Diseases focused on measuring Autoimmunity, Cell Mediated Immunity, S Antigen, Cell Proliferation, Uveitis, Cell Proliferation Assays, Auto-Antibody, Auto-Antigens
Eligibility Criteria
INCLUSION CRITERIA: Participant is 6 years or older. Adult participant is able to understand and sign the informed consent. If the participant is younger than 18 years of age at enrollment, has a parent or legal guardian who is able to understand and sign the consent on their behalf. Children must provide assent. Patients must have a diagnosis of an ocular inflammatory disease, AMD or diabetic retinopathy. EXCLUSION CRITERIA: The presence of non-ocular inflammatory disease. Unwilling or unable to provide a blood sample.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00357071
First Posted
July 26, 2006
Last Updated
July 25, 2018
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00357071
Brief Title
Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases
Official Title
Evaluation of Immune Responses to Different Antigens in Non Infectious Ocular Inflammatory Diseases
Study Type
Observational
2. Study Status
Record Verification Date
July 24, 2018
Overall Recruitment Status
Completed
Study Start Date
April 7, 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 24, 2018 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
This study will collect blood samples from patients with non-infectious eye inflammatory diseases a spectrum of eye disorders that can produce sight-threatening vision loss. The blood will be analyzed for substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments. Treatment is not offered under this protocol.
Patients 6 years of age and older with an eye inflammatory disease, including non-infectious uveitis, ocular cicatricial pemphigoid, non-infectious scleritis, episcleritis, Stevens Johnson syndrome, Moorens ulcer, peripheral ulcerative keratitis and keratoconjunctivitis sicca, may be eligible for this study. Patients may or may not currently be participating in a treatment trial.
Participants will have blood drawn through a needle in an arm vein. More samples may be collected if patients enrolled in another study are scheduled for additional visits. No more than 4 teaspoonfuls of blood will be collected at any one time.
Detailed Description
Ocular inflammatory diseases can lead to visual loss in adults as well as in children. These conditions are usually characterized by repeated exacerbations and remissions. The underlying cause of majority of these conditions is not clear even though an autoimmune mechanism has been implicated. Various studies have reported an altered immunological profile in these patients. An underlying immune mechanism has been thought to be playing a role in at least some of the ocular inflammatory diseases. In addition, evidence from literature also suggests inflammatory disease may be an important mechanism leading to Age related macular degeneration and Diabetic retinopathy, two leading causes for vision loss. However, very little is known about the involvement of immune components in these patients.
This protocol proposes to test for proliferative cell mediated and humoral responses against self-antigens from patients with ocular inflammatory diseases, AMD and diabetic retinopathy. Patients will be recruited from other ongoing protocols. An attempt would be made to find any correlation between the clinical disease and the immunological findings. These findings will not be used for diagnostic nor therapeutic purposes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
Keywords
Autoimmunity, Cell Mediated Immunity, S Antigen, Cell Proliferation, Uveitis, Cell Proliferation Assays, Auto-Antibody, Auto-Antigens
7. Study Design
Enrollment
219 (Actual)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Participant is 6 years or older.
Adult participant is able to understand and sign the informed consent. If the participant is younger than 18 years of age at enrollment, has a parent or legal guardian who is able to understand and sign the consent on their behalf. Children must provide assent.
Patients must have a diagnosis of an ocular inflammatory disease, AMD or diabetic retinopathy.
EXCLUSION CRITERIA:
The presence of non-ocular inflammatory disease.
Unwilling or unable to provide a blood sample.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice N Sen, M.D.
Organizational Affiliation
National Eye Institute (NEI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
382859
Citation
Foster CS, Kenyon KR, Greiner J, Greineder DK, Friedland B, Allansmith MR. The immunopathology of Mooren's ulcer. Am J Ophthalmol. 1979 Aug;88(2):149-59. doi: 10.1016/0002-9394(79)90459-8.
Results Reference
background
PubMed Identifier
735597
Citation
Kriukova ME, Bocharova-Messner OM, Stefanov SB. [Shape factor of myofibril cross sections of functionally different muscles of the cricket Acheta domestica]. Zh Evol Biokhim Fiziol. 1978 Nov-Dec;14(6):571-5. No abstract available. Russian.
Results Reference
background
PubMed Identifier
6230102
Citation
Murray PI, Rahi AH. Pathogenesis of Mooren's ulcer: some new concepts. Br J Ophthalmol. 1984 Mar;68(3):182-7. doi: 10.1136/bjo.68.3.182.
Results Reference
background
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Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases
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