Clinical trial NCT00001310: Tissue Studies of Human Eye Diseases
Official title: Immunopathology and Molecular Pathology of Ocular Diseases in Humans
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Retinal Disease
Corneal Disease
Diabetic Retinopathy
Uveitis
Age-Related Macular Degeneration
Keywords: Retinal Disease
Diabetic Retinopathy
Uveitis
Age-Related Macular Degeneration
Corneal Disease
Ocular Disease
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 3833
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The purpose of this project is to diagnose and evaluate ocular and related tissues with various diseases such as conjunctival, corneal, uveal, vitreoretinal and optic nerve disorders, ocular degenerative, metabolic or genetic diseases and tumors. These will be studied using light microscopy, electron microscopy, confocal microscopy, immunohistochemistry, molecular pathological including polymerase chain reaction and in situ hybridization, as well as measuring the functions of cellular organelles, e.g., mitochondrial function. Lymphocytes in the peripheral blood as well as other involved biopsied tissues and ocular tissue will be compared and categorized by disease. Cytokines, chemokines or growth factors and/or other released molecules in the blood and ocular fluids will be also analyzed. Elucidating the relationship between the infiltrating cells, ocular resident cells, and their products in various diseases will help us to make diagnoses and increase our understanding of human ocular disorders.

Patients who require eye surgery to treat an eye disease or other disease in which the eye is involved may participate in this study. Samples of eye tissue and fluid that are normally removed and discarded during eye surgery will instead be given to researchers for study. The tissues will be examined under microscope and studied using sophisticated chemical and biological tests. Immune cells from blood samples may also be examined. These studies will help better understand and diagnose the various eye diseases and to develop more attractive therapies.

Detailed description: The purpose of this project is to diagnose and evaluate ocular and related tissues with various diseases such as conjunctival, corneal, uveal, vitreoretinal, scleral, optic nerve, and orbital disorders, ocular degenerative, inflammatory, metabolic or genetic diseases, and tumors. These will be studied using light microscopy, electron microscopy, confocal microscopy, immunohistochemistry, molecular pathology including microdissection and polymerase chain reaction and in situ hybridization, ELISA, as well as measuring the functions of cellular organelles, e.g., mitochondrial function. Lymphocytes in the peripheral blood, serum, as well as other involved biopsied tissues and ocular tissue will be compared and categorized by disease and normal. Cytokines, chemokines, growth factors, antibodies, and/or other released molecules in the blood, CSF, and ocular fluids will be also analyzed. We will compare the tissue morphology as well as immunological and biochemical indexes, e.g., cytokine/chemokine levels, growth factors, and antibodies between the diseases and normals. Elucidating the relationship between the infiltrating cells, ocular resident cells, and their products in various diseases will help us to make diagnoses, increase our understanding of human ocular disorders, and assist therapy.

Eligibility criteria: * INCLUSION CRITERIA:

Up to 5,000 subjects will be enrolled in the study at all sites combined. Subjects will be enrolled at NEI.

1. Participants must be undergoing an eye procedure for clinical care of their condition which requires the removal of tissue specimens or have agreed pre-mortem to donate their eyes after death for research purposes.
2. Participants must agree to the de-identified storage of their sample for potential use in future research projects.
3. For conditions where blood is needed for analysis, participants must consent to having blood drawn for research evaluation, and be able to safely give a blood sample.
4. Participants must be able to give informed consent for themselves and/or their minor children who wish to enroll.

EXCLUSION CRITERIA:

1. Participant is unwilling or unable to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Eye Institute (NEI)
name: Robert B Nussenblatt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan CC. Molecular pathology of primary intraocular lymphoma. Trans Am Ophthalmol Soc. 2003;101:275-92.
citation: Ding X, Patel M, Chan CC. Molecular pathology of age-related macular degeneration. Prog Retin Eye Res. 2009 Jan;28(1):1-18. doi: 10.1016/j.preteyeres.2008.10.001. Epub 2008 Nov 6.
citation: Chan CC, Li Q. Immunopathology of uveitis. Br J Ophthalmol. 1998 Jan;82(1):91-6. doi: 10.1136/bjo.82.1.91. No abstract available.