National Eye Institute Biorepository for Retinal Diseases
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|ClinicalTrials.gov Identifier: NCT01496625|
Recruitment Status : Recruiting
First Posted : December 21, 2011
Last Update Posted : May 24, 2022
- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time. They also want to study body tissues and blood to understand the nature of eye disease. Studying genes, cells, and tissues may help them understand why some people get eye problems and others do not, or why some people respond to treatment while others do not. Researchers want to collect physical samples and personal data to develop a National Eye Institute database.
- To collect health information and blood and tissue samples from people with and without eye diseases, to be used in research studies.
- Individuals of any age with different types of eye disease.
- Healthy volunteers with no history of eye disease.
- Participants may be recruited from National Eye Institute studies or may be referred from other sources.
- Participants will be screened with a physical exam and medical history. They will also have a full eye exam. Questions will be asked about family medical history, especially about eye disease.
- Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and urine, may be collected as needed. Adult participants may also provide a skin sample.
- Tissue or fluid from eye collected as part of eye care or treatment may also be added to the database.
- No treatment will be provided as part of this study.
|Condition or disease|
|Age-Related Macular Degeneration Diabetic Retinopathy Von Hippel-Lindau Syndrome Retinal Disease Retinal Vein Occlusion|
This protocol establishes a clinical database and biospecimen repository for potential use in subsequent research projects approved by the NIH IRB, such as the identification of novel factors relevant to the pathogenesis, progression, and response to treatment of a variety of retinal conditions, particularly age-related macular degeneration (AMD) and diabetic retinopathy and their associated systemic correlates of disease.
Objectives: This protocol provides for standardized collection of longitudinal clinical data and for serial collection, processing, and storage of a variety of biospecimens. The clinical data set and biospecimen repository may be used in subsequent potential research studies for purposes including identification of novel genetic factors, biomarkers, and experimental models associated with pathogenesis, progression, and response to treatment for various conditions of the retina and their associated systemic correlates of disease.
Study Population: We plan to accrue up to 200 participants with AMD, 125 participants with diabetic retinopathy, 200 participants with other retinal diseases, and 125 participants without any retinal disease. A total of up to 650 participants may be enrolled.
Design: This protocol is designed around prospective observation of multiple retinal diseases and suitable controls incorporating:
Defined testing and ocular imaging on a standardized follow-up schedule; and
Collection of biospecimens for research purposes for which sampling does not incur more than minimal risk to participants.
Outcome Measures: Potential outcome measures for subsequent studies using this data set may include the interaction of key parameters of phenotype (such as visual acuity and retinal features on ocular imaging) with genetic variants and other biomarkers identified from biospecimens, and the characterization of new experimental models of eye health and disease.
|Study Type :||Observational|
|Estimated Enrollment :||650 participants|
|Official Title:||NEI Intramural Biorepository for Retinal Diseases|
|Actual Study Start Date :||June 18, 2012|
Participants with age-related macular degeneration (AMD), diabetic retinopathy, and other retinal diseases.
Participants without any retinal diseases.
- Interaction of key parameters of phenotype with genetic variants, and characterization of new experimental models of eye health and disease. [ Time Frame: Ongoing ]Potential outcome measures for subsequent studies using this data set may include the interaction of key parameters of phenotype (such as visual acuity and retinal features on ocular imaging) with genetic variants and other biomarkers identified from biospecimens, and the characterization of new experimental models of eye health and disease.
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 ClinicalTrials.gov identifier (NCT number): NCT01496625
|Contact: Cathy Kangale-Whitney, R.N.||(301) firstname.lastname@example.org|
|Contact: Tiarnan DL Keenan, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Tiarnan DL Keenan, M.D.||National Eye Institute (NEI)|