Viewing Study NCT00357071



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Study NCT ID: NCT00357071
Status: COMPLETED
Last Update Posted: 2018-07-26
First Post: 2006-07-26

Brief Title: Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases
Sponsor: National Eye Institute NEI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Evaluation of Immune Responses to Different Antigens in Non Infectious Ocular Inflammatory Diseases
Status: COMPLETED
Status Verified Date: 2018-07-24
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
03-EI-0122 None None None