Retinal DiseaseNCT00001310
Tissue Studies of Human Eye Diseases
An observational study of Retinal Disease and Corneal Disease, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Disease, Corneal Disease, Diabetic Retinopathy
- How many people
- 3,833 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 1992to 16 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Up to 5,000 subjects will be enrolled in the study at all sites combined. Subjects will be enrolled at NEI.
- 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.
- Participants must agree to the de-identified storage of their sample for potential use in future research projects.
- 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.
- Participants must be able to give informed consent for themselves and/or their minor children who wish to enroll.
Who cannot join
- 1. Participant is unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Immunopathology and Molecular Pathology of Ocular Diseases in Humans
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.
Read the 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.
- 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
- Medical subject headings
- Retinal Diseases, Corneal Diseases, Diabetic Retinopathy, Uveitis, Macular Degeneration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start5 Mar 1992
- Study completion16 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,833 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert B Nussenblatt, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001310
- Sponsor's protocol ID
- 920113
- Other IDs
- 92-EI-0113
- Status last verified
- 16 Sep 2015
- First submitted
- 3 Nov 1999
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Chan CC. Molecular pathology of primary intraocular lymphoma. Trans Am Ophthalmol Soc. 2003;101:275-92.
PubMed 14971583Ding 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.
PubMed 19026761Chan 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.
PubMed 9536890
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunopathology and Molecular Pathology of Ocular Diseases in Humans
- ClinicalTrials.gov ID
- NCT00001310
- Acronym / sponsor ID
- 920113
- 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
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 3,833 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 5 Mar 1992
- Study completion
- 16 Sep 2015
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Up to 5,000 subjects will be enrolled in the study at all sites combined. Subjects will be enrolled at NEI.
- 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.
- Participants must agree to the de-identified storage of their sample for potential use in future research projects.
- 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.
- Participants must be able to give informed consent for themselves and/or their minor children who wish to enroll.
Key exclusion criteria (1 listed)
- 1. Participant is unwilling or unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 14971583Chan CC. Molecular pathology of primary intraocular lymphoma. Trans Am Ophthalmol Soc. 2003;101:275-92.
- Background: PubMed 19026761Ding 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.
- Background: PubMed 9536890Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert B Nussenblatt, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease and Corneal Disease, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001310, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.