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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 12, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Study Description
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Brief Summary:

Background:

- 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.

Objectives:

- To collect health information and blood and tissue samples from people with and without eye diseases, to be used in research studies.

Eligibility:

  • Individuals of any age with different types of eye disease.
  • Healthy volunteers with no history of eye disease.

Design:

  • 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

Detailed Description:

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:

  1. Defined testing and ocular imaging on a standardized follow-up schedule; and
  2. 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 Design
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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NEI Intramural Biorepository for Retinal Diseases
Actual Study Start Date : June 18, 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Cohort 1
Participants with age-related macular degeneration (AMD), diabetic retinopathy, andother retinal diseases.
Cohort 2
Participants without any retinal diseases.


Outcome Measures
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Primary Outcome Measures :
  1. Interaction of key parameters of phenotype (like visual acuity, retinal features on ocular imaging) with genetic variants and other biomarkers identified from biospecimens; and characterization of new experimental models of eye health and di... [ Time Frame: Ongoing ]
    the interaction of key parameters of phenotype with genetic variants and other biomarkers identified from biospecimens, and the characterization of new experimental models of eye health and disease


Eligibility Criteria
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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:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study accrual goal is 100 participants with AMD, 200 participants with diabetic retinopathy, up to 200 participants with other retinal diseases, and 150 participants without any retinal disease. Accordingly, total accrual is up to 650 participants.Participants may enroll in this study after referral by a medical practitioner in the private sector, or by another clinic, hospital, or medical institution. Participants may enroll in this study concurrently with another NEI or NIH protocol, or following completion of another study. Self-referral will be permitted. Advertisements will not be used.
Criteria
  • INCLUSION CRITERIA:

Participants will be eligible if they:

  • Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children.
  • Manifest diagnosed or undiagnosed retinal disease, or could serve as an unaffected control suitable for comparison to participants with various retinal diseases, particularly AMD and diabetic retinopathy (taking into account matching factors such as age and past ocular history).

EXCLUSION CRITERIA:

Participants will not be eligible if they:

  • Are unable or unwilling to give informed consent that includes collection and study of at least one peripheral blood sample.
  • Are unable or unwilling to give informed consent that includes use of NIH medical records and clinical samples for research.
  • Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01496625


Contacts
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Contact: Anne M Alvarez, R.N. (301) 496-0097 annemarie.alvarez@nih.gov
Contact: Tiarnan DL Keenan, M.D. (301) 451-6330 tiarnan.keenan@nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Tiarnan DL Keenan, M.D. National Eye Institute (NEI)
More Information
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Additional Information:

Publications:

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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT01496625    
Other Study ID Numbers: 120042
12-EI-0042
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 6, 2021
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Biological Specimens
Retinal Disease
Diabetic Retinopathy
Phenotype-Genotype correlation
 Age-Related Macular Degeneration (AMD)
AMD
Healthy Volunteer
HV
Additional relevant MeSH terms:
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Von Hippel-Lindau Disease
Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Retinal Vein Occlusion
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
 Endocrine System Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Neurocutaneous Syndromes
Nervous System Diseases
Angiomatosis
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn