Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases

NCT ID: NCT00357071

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-07

Study Completion Date

2018-07-24

Brief Summary

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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

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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.

Conditions

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Eye Diseases

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hatice N Sen, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Eye Institute (NEI)

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 382859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 735597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6230102 (View on PubMed)

Other Identifiers

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03-EI-0122

Identifier Type: -

Identifier Source: secondary_id

030122

Identifier Type: -

Identifier Source: org_study_id

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