Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases

Tracking Information
First Submitted Date	July 26, 2006
First Posted Date	July 27, 2006
Last Update Posted Date	March 29, 2018
Study Start Date	April 7, 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00357071 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
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
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.
Study Type	Observational
Study Design	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Eye Diseases
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	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.; 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. Russian.; Murray PI, Rahi AH. Pathogenesis of Mooren's ulcer: some new concepts. Br J Ophthalmol. 1984 Mar;68(3):182-7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Enrolling by invitation
Actual Enrollment; (submitted: July 20, 2017)	220
Original Enrollment; (submitted: July 26, 2006)	200
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
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.
Sex/Gender	Sexes Eligible for Study: All
Ages	6 Years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00357071
Other Study ID Numbers	030122; 03-EI-0122
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
Study Sponsor	National Eye Institute (NEI)
Collaborators	Not Provided
Investigators	Principal Investigator: Hatice N Sen, M.D. National Eye Institute (NEI)
PRS Account	National Institutes of Health Clinical Center (CC)
Verification Date	January 29, 2018