NEI Age-Related Eye Disease Study (AREDS)

The Age-Related Eye Disease Study (AREDS) was initially designed as a long-term multi-center, prospective study of the clinical course of age-related macular degeneration (AMD) and age-related cataract. In addition to collecting natural history data, AREDS included a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. AREDS participants were 55 to 80 years of age at enrollment and had to be free of any illness or condition that would make long-term follow-up or compliance with study medications unlikely or difficult. On the basis of fundus photographs graded by a central reading center, best-corrected visual acuity and ophthalmologic evaluations, 4,757 participants were enrolled in one of several AMD categories, including persons with no AMD. The clinical trials for AMD and cataract were conducted concurrently. AREDS participants were followed on the clinical trials for a median time of 6.5 years. Subsequent to the conclusion of the clinical trials, participants were followed for an additional 5 years and natural history data were collected. The AREDS research design is detailed in AREDS Report 1. AREDS Report 8 contains the mainline results from the AMD trial; AREDS Report 9 contains the results of the cataract trial. Blood samples were also collected from 3,700+ AREDS participants for genetic research. Genetic samples from 600 AREDS participants (200 controls, 200 Neovascular AMD cases, and 200 Geographic Atrophy cases) were selected using data available in March 2005 and then were evaluated with a genome-wide scan. These data, as well as selected phenotypic data, were made available in the dbGaP. DNA from AREDS participants, which is currently being stored in the AREDS Genetic Repository, is available for research purposes. However, not all of the 3,700+ AREDS participants who submitted a blood sample currently have DNA available. In addition to including the data from the genome-wide scan on the 600 original samples, this second version of the AREDS dbGaP database provides a comprehensive set of data tables with extensive clinical information collected for the 4,757 participants who participated in AREDS. The tables include information collected at enrollment/baseline, during study follow-up, fundus and lens pathology, nutritional estimates, quality of life measures and measures of morbidity and mortality. In November 2010, over 72,000 high quality fundus and lens photographs of 595 AREDS participants (of the original 600 selected for the genome-wide scan) were made available in the AREDS dbGaP. In addition to the genome-wide scan data, the fundus and lens grading data for these participants are also available through the AREDS dbGaP. Details about the ocular photographs that are available may be found in the document "Age-Related Eye Disease Study (AREDS) Ocular Photographs". In January 2012, a measure of daily sunlight exposure was added in a separate "sunlight" table. Furthermore, the "followup" table has been revised. The visual acuity for the right eye was inadvertently missing at odd-numbered visits (01, 03, 05, etc.). This data is now part of the table. In February 2014 over 134,500 high-quality fundus photographs (macular field F2) of 4613 AREDS participants were added to the existing AREDS dbGaP resource. The AREDS dbGaP image archive already contains over 72,000 high quality fundus and lens photographs of 595 AREDS participants for whom dbGaP-accessible genotype data exist. Information about the available ocular photographs found in the document "Age-Related Eye Disease Study (AREDS) Ocular Photographs" has been updated with an addendum. It is hoped that this resource will better help researchers understand two important diseases that affect an aging population. These data may be applied to examination and inference on genetic and genetic-environmental bases for age-related diseases of public health significance and may also help elucidate the clinical course of both conditions, generate hypotheses, and aid in the design of clinical trials of preventive interventions. Definitions of Final AMD Phenotype Categories Please see phd001138.1 for a detailed description of how AREDS participants' final AMD phenotype was categorized. User's Guide for AREDS Phenotype Data A detailed User's Guide for the AREDS phenotype data is available. This User's Guide is meant to be a comprehensive document which explains the complexities of the AREDS data. It is recommended that all researchers using AREDS phenotype data make use of this User's Guide. ]]>
BACKGROUND AND RATIONALE, Chapter 1LITERATURE REVIEW, Chapter 2STUDY DESIGN , Chapter 3STUDY RATIONALIZATION, Chapter 4STUDY POLICIES, Chapter 5EXAMINATION SCHEDULE, Chapter 6EXAMINATION PROCEDURES , Chapter 7PHOTOGRAPHIC PROCEDURES , Chapter 8CERTIFICATION OF STAFF AND CLINICS, Chapter 9DESCRIPTION OF INTERVENTION, Chapter 10DATA ANALYSIS AND REPORTING , Chapter 11QUALITY ENHANCEMENT, Chapter 12CLINICAL CENTER PROCEDURES, Chapter 13COORDINATING CENTER PROCEDURES , Chapter 14READING CENTER PROCEDURES , Chapter 15INTERVENTION MANUFACTURER'S PROCEDURES , Chapter 16INTERVENTION PACKAGING AND DISTRIBUTION PROCEDURES , Chapter 17PROCEDURES FOR CENTRAL LABORATORY SPECIMEN COLLECTING, SHIPPING AND PROCESSING, Chapter 18MANUAL OF OPERATIONS — PHASE III, Chapter 19BASELINE INTERVIEW — PHASE IISUNLIGHT EXPOSURE QUESTIONNAIRE — PHASE IIMISSED VISIT — PHASE llADVERSE EXPERIENCE REPORT — PHASE IIQUALIFICATION - PHASE IIHOSPITALIZATION-PHASE IIDEATH REPORT — PHASE IISUPPLEMENTATION RECORD AND ADHERENCE WORKSHEET - PHASE IIFAMILY HISTORY - GENETICS - PHASE IIPARTICIPANT APPROVAL OF GENETICS BLOOD SAMPLE USEPROTOCOL ANOMALY - PHASE IINUTRITION QUESTIONNAIRENATIONAL EYE INSTITUTE VISUAL FUNCTIONING QUESTIONNAIRE - 25 (VFQ-25)ANNUAL VISIT FOLLOWUP - PHASE IIBLOOD DRAWING QUESTIONNAIRE — PHASE IIPARALLEL STUDIES INFORMATION FORMNONANNUAL VISIT FOLLOWUP - PHASE IIELIGIBILITY AND RANDOMIZATION - PHASE IICONTACT FORM - PHASE IIIDETAILED LENS GRADING FORMFOLLOWUP INTERVIEW - PHASE IIIIN-CLINIC VISIT FOLLOW-UP - PHASE IIIMaculopathy Grading FormMORBIDITY AND MORTALITY DATA SHEETSUPPLEMENTATION REASSIGNMENT - PHASE IIVITAMIN USAGE FORM - PHASE IIIDefinitions of Final Age-Related Macular Degeneration (AMD) Phenotype CategoriesAREDS dbGaP Data Tables: A User's GuideAge-Related Eye Disease Study (AREDS) Ocular Photographs This analysis of association between allele and the AMD status variable (amdstat) from the National Eye Institute Age-Related Eye Disease Study (AREDS) was pre-computed by NCBI. It contained 395 cases and 198 controls. Case individuals have been diagnosed as having non-vascular AMD (198), geographic atrophy (133), both non-vascular AMD and geographic atrophy (50), or large drusen (14). Genotyping was conducted by the Center for Inherited Disease Research (CIDR) using the Illumina Sentrix Human-1 Genotyping Beadchip. This analysis of association between allele and the AMD status variable (amdstat) from the National Eye Institute Age-Related Eye Disease Study (AREDS) was pre-computed by NCBI. It contained 350 cases and 171 controls. Genotyping was conducted by the Center for Inherited Disease Research (CIDR) using Affymetrix GeneChip Human Mapping 100K Set pre-computed by NCBI. It contained 381 cases and 187 controls. The case group includes individuals whose final AMD phenotype is neovascular AMD (197), geographic atrophy (133), or both neovascular AMD and geographic atrophy (51). The control group includes individuals whose final AMD phenotype is Control (151), Control Questionable 1 (14), Control Questionable 2 (1), or Control Questionable 4 (21). Participants whose final AMD phenotype is Large Drusen (2), Large Drusen Questionable 2 (1), Questionable Advanced AMD (12), or Other, non-control (10) were not included in the analyses. Participants were originally selected for genotyping prior to final AMD phenotype information being available. Analyses are adjusted for age at last fundus photograph, gender, and smoking status at baseline. Genotyping was conducted by the Center for Inherited Disease Research (CIDR) using the Illumina Sentrix Human-1 Genotyping Beadchip.
]]>Please see AREDS Manual of Operations Section 3.1.3 for a detailed description of the inclusion and exclusion criteria. ]]>
AREDS Time Line November 1992 - first qualifying visit February 1993 - first randomization visit December 1993 - first annual visit February 1994 - release of Finnish study results December 1994 - second annual visits January 1996 - release of Caret study results March 1996 - implementation of sunlight exposure questionnaire (SEQ) and reassignment of smokers to non-antioxidant study medications April 1997 - implementation of visual function questionnaire with appendix (NEI VFQ) January 1998 - implementation of 5th year follow-up interview, approval of genetics ancillary study, and end of recruitment May 1998 - first blood drawn for genetics ancillary study June 2000 - implementation of cognitive function protocol; April 2001 - last phase II study visit Fall 2001 - trial results announced and initiation of phase III December 2005 - end of study ]]>