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Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00357071
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : July 26, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

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.

Condition or disease
Eye Diseases

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.

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Study Type : Observational
Actual Enrollment : 219 participants
Official Title: Evaluation of Immune Responses to Different Antigens in Non Infectious Ocular Inflammatory Diseases
Study Start Date : April 7, 2003
Study Completion Date : July 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

    1. Participant is 6 years or older.
    2. 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.
    3. Patients must have a diagnosis of an ocular inflammatory disease, AMD or diabetic retinopathy.


  1. The presence of non-ocular inflammatory disease.
  2. Unwilling or unable to provide a blood sample.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00357071

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
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Principal Investigator: Hatice N Sen, M.D. National Eye Institute (NEI)
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Responsible Party: National Eye Institute (NEI) Identifier: NCT00357071    
Other Study ID Numbers: 030122
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 24, 2018
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Cell Mediated Immunity
S Antigen
Cell Proliferation
Cell Proliferation Assays
Additional relevant MeSH terms:
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Eye Diseases