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The Age-Related Eye Disease Study (AREDS): Design implications AREDS report no. 1

Authors

Kassoff, A Kieval, S Mehu, M Buehler, J Eglow, M Kaufman, F Margherio, RR Cox, MS Garretson, B Hassan, T Ruby, A Trese, MT Werner, JC Williams, GA Regan, V Manatrey, P Cumming, K Zajechowski, M Falk, R Streasick, P Szydlowski, L Dreyer, RF Ma, C Beardsley, C Crider, H Capone, A Aaberg, TM Martin, D Saperstein, D Sternberg, P Curtis, L Stribling, B Gilman, J Myles, B Swords, R Orth, DH Flood, TP Civantos, J deBustros, S Packo, KH MacLeod, C Morrison, C Bryant, DA Doherty, D Sandoval, S Seddon, JM Pinnolis, MK Jones-Devonish, DA Crouse, VD Snow, KK Evans, C Davis, N Callahan, C Walsh, D Dubois, J Burton, I Ferris, FL Chew, EY Csaky, K McCarthy, SA Dabas, KH Goodman, L Kim, YJ Lopez, P Mercer, R Ayres, LM LaRean, T Randall, A Chicca, M Ciatto, PF Kuehl, E Kivitz, I Koutsandreas, D Friberg, TR Eller, A Gorin, MB Alexander, J Mack, B Bressler, SB Bressler, NM Cassel, G Goldberg, M Haller, JA Ratner, L Schachat, AP Sherman, SH Sunness, JS Schenning, S Sackett, C Cain, D Emmert, D George, T Wheeler, S Elman, MJ Ballinger, R Betancourt, A Glasser, D Lammlein, J Seff, R Shuman, M Starr, J Carrigan, A Ringrose, C Mathews, T Sotirakos, P Cain, T Chandra, SR Myers, FL Nork, TM Stevens, T Blodi, B Gottlieb, J Perkins, T Blatz, M Walker, W Harrison, B Knutson, G Krolnik, D Somers, G Davis, MD Klein, BEK Klein, R Hubbard, L Magli, YL Brickbauer, J Ansay, S Armstrong, J Neider, M Wabers, H Baliker, J Kastorff, L Laher, K Badal, D Geithman, PL Miner, KD King, WN Osterly, KR Dohm, KL Onofrey, JA Esser, B Hurtenback, C Fisher, MR Robinson, NL Reimers, J Miller, D Bowman, B Gunter, E Sowell, A Lindblad, AS Ederer, F Milton, RC Gensler, G Anand, R Entler, G Stine, E Berlin, SH Scholl, PR Mengers, SA Ferris, FL Chew, EY Sperduto, R Kurinij, N

Citation

A. Kassoff et al., The Age-Related Eye Disease Study (AREDS): Design implications AREDS report no. 1, CONTR CL TR, 20(6), 1999, pp. 573-600

Citations number

Categorie Soggetti

Pharmacology,"Medical Research General Topics

Journal title

CONTROLLED CLINICAL TRIALS

ISSN journal

01972456 → ACNP

Volume

Issue

Year of publication

1999

Pages

573 - 600

Database

ISI

SICI code

0197-2456(199912)20:6<573:TAEDS(>2.0.ZU;2-B

Abstract

The Age-Related Eye Disease Study (AREDS) was initially conceived as a long -term multicenter, prospective study of the clinical course of age-related macular degeneration (AMD) and age-related cataract. Data on progression ra tes and risk factors from the study will increase understanding of the clin ical course of both conditions, generate hypotheses about etiology, and aid in the design of clinical trials of potential interventions. In addition t o collecting natural history data, AREDS includes a clinical trial of high- dose vitamin and mineral supplements for AMD and a clinical trial of high-d ose vitamin supplements for cataract. The clinical trials were initiated la rgely because of the widespread public use in the United States of commerci ally available pharmacologic doses of vitamins and minerals to treat these two eye conditions and the absence of definitive studies on the safety and efficacy of their use. Important design issues for the clinical trials incl ude: defining cataract and AMD, estimating event rates, determining the typ e and dosage of vitamins and minerals to be tested for each condition, and identifying the parameters necessary for monitoring safety and efficacy. Th is paper describes the AREDS design, including the study rationale and oper ational structure, and the approach adopted to combine, for two diseases, c linical trials with a natural history study. (C) Elsevier Science Inc. 1999 .