Recruiting

Observational Study

Sponsor:

National Eye Institute (NEI)

Code:

NCT01496625

Conditions

Age-Related Macular Degeneration

Diabetic Retinopathy

Von Hippel-Lindau Syndrome

Retinal Disease

Retinal Vein Occlusion

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Study Details

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 at least 2 years of 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.

Conditions

Age-Related Macular Degeneration

Diabetic Retinopathy

Von Hippel-Lindau Syndrome

Retinal Disease

Retinal Vein Occlusion

Study ID

NCT01496625

Start date

Jun 18, 2012

Status verified date

Sep 3, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Participants with age-related macular degeneration (AMD), diabetic retinopathy, and other retinal diseases.

Cohort 2

Participants without any retinal diseases.

Primary outcome measure

  • The intent is to collect data on a variety of phenotypic parameters and to store biospecimens in a manner that permits a broad array of potential testing and experimentation in the future. [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Eye Institute (NEI)

Last update posted

Sep 8, 2026

Last verified

Sep 3, 2026

Keywords

  • Biological Specimens
  • Retinal Disease
  • Diabetic Retinopathy
  • Phenotype-Genotype correlation
  • Age-Related Macular Degeneration (AMD)
  • Natural History
  • AMD
  • Healthy Volunteer
  • HV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Eye Institute (NEI) on 2026-09-08.