Blood and Saliva Sample Collection for AREDS 2

Completed

• Conditions: Age-Related Macular Degeneration; Eye Diseases

• Registration Number: NCT01553474
• Lead Sponsor: National Eye Institute (NEI)

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-02-24
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Status Verified: 2013-02-05
• Study Completion: 2013-02-05
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States