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Protocol Details

NEI Intramural Biorepository for Retinal Diseases

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-EI-0042

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Biological Specimens;
Retinal Disease;
Diabetic Retinopathy;
Phenotype-Genotype correlation;
Age-Related Macular Degeneration (AMD);
Natural History

Recruitment Keyword(s)

Retinal Disease;
Age-Related Macular Degeneration (AMD);
AMD;
Diabetic Retinopathy;
Healthy Volunteer;
HV

Condition(s)

Age-Related Macular Degeneration;
Diabetic Retinopathy;
Von Hippel-Lindau Syndrome;
Retinal Disease;
Retinal Vein Occlusion

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Eye Institute

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.

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Eligibility

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(s), 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.


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Citations:

Wiggs JL. Genomic promise: personalized medicine for ophthalmology. Arch Ophthalmol. 2008 Mar;126(3):422-3.

Baird PN, Hageman GS, Guymer RH. New era for personalized medicine: the diagnosis and management of age-related macular degeneration. Clin Experiment Ophthalmol. 2009 Nov;37(8):814-21.

Brooks BP, Macdonald IM, Tumminia SJ, Smaoui N, Blain D, Nezhuvingal AA, Sieving PA; National Ophthalmic Disease Genotyping Network (eyeGENE). Genomics in the era of molecular ophthalmology: reflections on the National Ophthalmic Disease Genotyping Network (eyeGENE). Arch Ophthalmol. 2008 Mar;126(3):424-5.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Tiarnan D. Keenan, M.D.
National Eye Institute (NEI)
NIHBC 10 - CLINICAL CENTER BG RM 10D45
10 CENTER DR
BETHESDA MD 20892
(301) 451-6330
tiarnan.keenan@nih.gov

Cathy Kangale-Whitney, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 402-4174
cathy.kangale-whitney@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01496625

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