National Eye Institute Biorepository for Retinal Diseases

Diabetic Retinopathy Clinical Trial

Official title:

NEI Intramural Biorepository for Retinal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01496625
• Other study ID #: 120042
• Secondary ID: 12-EI-0042
• Status: Recruiting
• Start date: June 18, 2012

Study information

• Verified date: May 31, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Cathy Kangale-Whitney, R.N.
• Phone: (301) 402-4174
• Email: cathy.kangale-whitney[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Baird PN, Hageman GS, Guymer RH. New era for personalized medicine: the diagnosis and management of age-related macular degeneration. Clin Exp Ophthalmol. 2009 Nov;37(8):814-21. doi: 10.1111/j.1442-9071.2009.02136.x. — View Citation

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. doi: 10.1001/archopht.126.3.424. No abstract available. — View Citation

Wiggs JL. Genomic promise: personalized medicine for ophthalmology. Arch Ophthalmol. 2008 Mar;126(3):422-3. doi: 10.1001/archopht.126.3.422. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interaction of key parameters of phenotype with genetic variants, and characterization of new experimental models of eye health and disease.	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.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page