Blood and Saliva Sample Collection for AREDS 2

Age-Related Macular Degeneration Clinical Trial

Official title:

Blood and Saliva Sample Collection and Submission to the Age-Related Eye Disease Study 2 (AREDS2) Genetic Repository

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553474
• Other study ID #: 120085
• Secondary ID: 12-EI-0085
• Status: Completed
• Start date: February 24, 2012
• Est. completion date: February 5, 2013

Study information

• Verified date: February 5, 2013
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

• The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study participants will provide blood and saliva samples. The samples will be stored for research on eye diseases.

Objectives:

• To collect blood and saliva samples for AREDS 2 research.

Eligibility:

• AREDS 2 research study participants.

Design:

• Participants will provide blood and saliva samples.

• The samples will be submitted with personal and medical information. This information will be collected during the AREDS 2 procedures.

Description:

AREDS2 is a multi-center, Phase III, randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) as a treatment for age-related macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective, the AREDS2 study will provide information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 will also seek to validate the fundus photographic AMD scale developed from AREDS.

The objective of this protocol is to have AREDS2 participants submit blood and saliva samples to the AREDS2 Genetic Repository (Fisher BioServices, Rockville, MD) in order to provide further materials for the study of the genetic and biochemical bases for eye disease and possibly other diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 5, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

• INCLUSION CRITERIA:

Participants will be eligible if they were enrolled in the AREDS2 protocol and willing to have their blood drawn and saliva collected.

EXCLUSION CRITERIA:

Participants will not be eligible if they were not enrolled in AREDS2 and are not willing to have their blood drawn and saliva collected.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Eye Diseases
• Macular Degeneration

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States,