The age-related eye disease study (AREDS): Design implications AREDS report no. 1

A. S. Lindblad; A. Kassoff; S. Kieval; M. Mehu; J. Buehler; M. Eglow; F. Kaufman; R. R. Margherio; M. S. Cox; B. Garretson; T. Hassan; A. Ruby; M. T. Trese; J. C. Werner; G. A. Williams; V. Regan; P. Manatrey; K. Cumming; M. Zajechowski; R. Falk; P. Streasick; L. Szydlowski; R. F. Dreyer; C. Ma; C. Beardsley; H. Crider; Jr Capone A.; T. M. Aaberg; D. Martin; D. Saperstein; Jr Sternberg P.; L. Curtis; B. Stribling; J. Gilman; B. Myles; R. Swords; D. H. Orth; T. P. Flood; J. Civantos; S. DeBustros; K. H. Packo; C. MacLeod; C. Morrison; D. A. Bryant; D. Doherty; S. Sandoval; J. M. Seddon; M. K. Pinnolis; D. A. Jones-Devonish; V. D. Crouse; K. K. Snow; C. Evans; N. Davis; C. Callahan; D. Walsh; J. Dubois; I. Burton; F. L. Ferris; E. Y. Chew; K. Csaky; S. A. McCarthy; K. H. Dabas; L. Goodman; Ja Kim Young Ja Kim; P. Lopez; R. Mercer; L. M. Ayres; T. LaRean; A. Randall; M. Chicca; P. F. Ciatto; E. Kuehl; I. Kivitz; D. Koutsandreas; T. R. Friberg; A. Eller; M. B. Gorin; J. Alexander; B. Mack; S. B. Bressler; N. M. Bressler; G. Cassel; M. Goldberg; J. A. Haller; L. Ratner; A. P. Schachat; S. H. Sherman; J. S. Sunness; S. Schenning; C. Sackett; D. Cain; D. Emmert; T. George; S. Wheeler; M. J. Elman; R. Ballinger; A. Betancourt; D. Glasser; J. Lammlein

doi:10.1016/S0197-2456(99)00031-8

The age-related eye disease study (AREDS): Design implications AREDS report no. 1

A. S. Lindblad, A. Kassoff, S. Kieval, M. Mehu, J. Buehler, M. Eglow, F. Kaufman, R. R. Margherio, M. S. Cox, B. Garretson, T. Hassan, A. Ruby, M. T. Trese, J. C. Werner, G. A. Williams, V. Regan, P. Manatrey, K. Cumming, M. Zajechowski, R. FalkP. Streasick, L. Szydlowski, R. F. Dreyer, C. Ma, C. Beardsley, H. Crider, Jr Capone A., T. M. Aaberg, D. Martin, D. Saperstein, Jr Sternberg P., L. Curtis, B. Stribling, J. Gilman, B. Myles, R. Swords, D. H. Orth, T. P. Flood, J. Civantos, S. DeBustros, K. H. Packo, C. MacLeod, C. Morrison, D. A. Bryant, D. Doherty, S. Sandoval, J. M. Seddon, M. K. Pinnolis, D. A. Jones-Devonish, V. D. Crouse, K. K. Snow, C. Evans, N. Davis, C. Callahan, D. Walsh, J. Dubois, I. Burton, F. L. Ferris, E. Y. Chew, K. Csaky, S. A. McCarthy, K. H. Dabas, L. Goodman, Ja Kim Young Ja Kim, P. Lopez, R. Mercer, L. M. Ayres, T. LaRean, A. Randall, M. Chicca, P. F. Ciatto, E. Kuehl, I. Kivitz, D. Koutsandreas, T. R. Friberg, A. Eller, M. B. Gorin, J. Alexander, B. Mack, S. B. Bressler, N. M. Bressler, G. Cassel, M. Goldberg, J. A. Haller, L. Ratner, A. P. Schachat, S. H. Sherman, J. S. Sunness, S. Schenning, C. Sackett, D. Cain, D. Emmert, T. George, S. Wheeler, M. J. Elman, R. Ballinger, A. Betancourt, D. Glasser, J. Lammlein

Research output: Contribution to journal › Article › peer-review

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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 rates and risk factors from the study will increase understanding of the clinical course of both conditions, generate hypotheses about etiology, and aid in the design of clinical trials of potential interventions. In addition to collecting natural history data, AREDS includes a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. The clinical trials were initiated largely because of the widespread public use in the United States of commercially 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 include: defining cataract and AMD, estimating event rates, determining the type and dosage of vitamins and minerals to be tested for each condition, and identifying the parameters necessary for monitoring safety and efficacy. This paper describes the AREDS design, including the study rationale and operational structure, and the approach adopted to combine, for two diseases, clinical trials with a natural history study.

Original language	English (US)
Pages (from-to)	573-600
Number of pages	28
Journal	Controlled clinical trials
Volume	20
Issue number	6
DOIs	https://doi.org/10.1016/S0197-2456(99)00031-8
State	Published - Dec 1999
Externally published	Yes

Keywords

Age-related macular degeneration
Antioxidants
Beta-carotene
Cataract
Clinical course
Clinical trial
Vitamin C
Vitamin E
Zinc

ASJC Scopus subject areas

Pharmacology

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10.1016/S0197-2456(99)00031-8

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Lindblad, A. S., Kassoff, A., Kieval, S., Mehu, M., Buehler, J., Eglow, M., Kaufman, F., Margherio, R. R., Cox, M. S., Garretson, B., Hassan, T., Ruby, A., Trese, M. T., Werner, J. C., Williams, G. A., Regan, V., Manatrey, P., Cumming, K., Zajechowski, M., ... Lammlein, J. (1999). The age-related eye disease study (AREDS): Design implications AREDS report no. 1. Controlled clinical trials, 20(6), 573-600. https://doi.org/10.1016/S0197-2456(99)00031-8

Lindblad, AS, 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., J, Aaberg, TM, Martin, D, Saperstein, D, Sternberg P., J, 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, Young Ja Kim, JK, 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 1999, 'The age-related eye disease study (AREDS): Design implications AREDS report no. 1', Controlled clinical trials, vol. 20, no. 6, pp. 573-600. https://doi.org/10.1016/S0197-2456(99)00031-8

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title = "The age-related eye disease study (AREDS): Design implications AREDS report no. 1",

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 rates and risk factors from the study will increase understanding of the clinical course of both conditions, generate hypotheses about etiology, and aid in the design of clinical trials of potential interventions. In addition to collecting natural history data, AREDS includes a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. The clinical trials were initiated largely because of the widespread public use in the United States of commercially 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 include: defining cataract and AMD, estimating event rates, determining the type and dosage of vitamins and minerals to be tested for each condition, and identifying the parameters necessary for monitoring safety and efficacy. This paper describes the AREDS design, including the study rationale and operational structure, and the approach adopted to combine, for two diseases, clinical trials with a natural history study.",

keywords = "Age-related macular degeneration, Antioxidants, Beta-carotene, Cataract, Clinical course, Clinical trial, Vitamin C, Vitamin E, Zinc",

author = "Lindblad, {A. S.} and A. Kassoff and S. Kieval and M. Mehu and J. Buehler and M. Eglow and F. Kaufman and Margherio, {R. R.} and Cox, {M. S.} and B. Garretson and T. Hassan and A. Ruby and Trese, {M. T.} and Werner, {J. C.} and Williams, {G. A.} and V. Regan and P. Manatrey and K. Cumming and M. Zajechowski and R. Falk and P. Streasick and L. Szydlowski and Dreyer, {R. F.} and C. Ma and C. Beardsley and H. Crider and {Capone A.}, Jr and Aaberg, {T. M.} and D. Martin and D. Saperstein and {Sternberg P.}, Jr and L. Curtis and B. Stribling and J. Gilman and B. Myles and R. Swords and Orth, {D. H.} and Flood, {T. P.} and J. Civantos and S. DeBustros and Packo, {K. H.} and C. MacLeod and C. Morrison and Bryant, {D. A.} and D. Doherty and S. Sandoval and Seddon, {J. M.} and Pinnolis, {M. K.} and Jones-Devonish, {D. A.} and Crouse, {V. D.} and Snow, {K. K.} and C. Evans and N. Davis and C. Callahan and D. Walsh and J. Dubois and I. Burton and Ferris, {F. L.} and Chew, {E. Y.} and K. Csaky and McCarthy, {S. A.} and Dabas, {K. H.} and L. Goodman and {Young Ja Kim}, {Ja Kim} and P. Lopez and R. Mercer and Ayres, {L. M.} and T. LaRean and A. Randall and M. Chicca and Ciatto, {P. F.} and E. Kuehl and I. Kivitz and D. Koutsandreas and Friberg, {T. R.} and A. Eller and Gorin, {M. B.} and J. Alexander and B. Mack and Bressler, {S. B.} and Bressler, {N. M.} and G. Cassel and M. Goldberg and Haller, {J. A.} and L. Ratner and Schachat, {A. P.} and Sherman, {S. H.} and Sunness, {J. S.} and S. Schenning and C. Sackett and D. Cain and D. Emmert and T. George and S. Wheeler and Elman, {M. J.} and R. Ballinger and A. Betancourt and D. Glasser and J. Lammlein",

year = "1999",

month = dec,

doi = "10.1016/S0197-2456(99)00031-8",

language = "English (US)",

volume = "20",

pages = "573--600",

journal = "Controlled clinical trials",

issn = "0197-2456",

publisher = "Elsevier BV",

number = "6",

}

TY - JOUR

T1 - The age-related eye disease study (AREDS)

T2 - Design implications AREDS report no. 1

AU - Lindblad, A. S.

AU - Kassoff, A.

AU - Kieval, S.

AU - Mehu, M.

AU - Buehler, J.

AU - Eglow, M.

AU - Kaufman, F.

AU - Margherio, R. R.

AU - Cox, M. S.

AU - Garretson, B.

AU - Hassan, T.

AU - Ruby, A.

AU - Trese, M. T.

AU - Werner, J. C.

AU - Williams, G. A.

AU - Regan, V.

AU - Manatrey, P.

AU - Cumming, K.

AU - Zajechowski, M.

AU - Falk, R.

AU - Streasick, P.

AU - Szydlowski, L.

AU - Dreyer, R. F.

AU - Ma, C.

AU - Beardsley, C.

AU - Crider, H.

AU - Capone A., Jr

AU - Aaberg, T. M.

AU - Martin, D.

AU - Saperstein, D.

AU - Sternberg P., Jr

AU - Curtis, L.

AU - Stribling, B.

AU - Gilman, J.

AU - Myles, B.

AU - Swords, R.

AU - Orth, D. H.

AU - Flood, T. P.

AU - Civantos, J.

AU - DeBustros, S.

AU - Packo, K. H.

AU - MacLeod, C.

AU - Morrison, C.

AU - Bryant, D. A.

AU - Doherty, D.

AU - Sandoval, S.

AU - Seddon, J. M.

AU - Pinnolis, M. K.

AU - Jones-Devonish, D. A.

AU - Crouse, V. D.

AU - Snow, K. K.

AU - Evans, C.

AU - Davis, N.

AU - Callahan, C.

AU - Walsh, D.

AU - Dubois, J.

AU - Burton, I.

AU - Ferris, F. L.

AU - Chew, E. Y.

AU - Csaky, K.

AU - McCarthy, S. A.

AU - Dabas, K. H.

AU - Goodman, L.

AU - Young Ja Kim, Ja Kim

AU - Lopez, P.

AU - Mercer, R.

AU - Ayres, L. M.

AU - LaRean, T.

AU - Randall, A.

AU - Chicca, M.

AU - Ciatto, P. F.

AU - Kuehl, E.

AU - Kivitz, I.

AU - Koutsandreas, D.

AU - Friberg, T. R.

AU - Eller, A.

AU - Gorin, M. B.

AU - Alexander, J.

AU - Mack, B.

AU - Bressler, S. B.

AU - Bressler, N. M.

AU - Cassel, G.

AU - Goldberg, M.

AU - Haller, J. A.

AU - Ratner, L.

AU - Schachat, A. P.

AU - Sherman, S. H.

AU - Sunness, J. S.

AU - Schenning, S.

AU - Sackett, C.

AU - Cain, D.

AU - Emmert, D.

AU - George, T.

AU - Wheeler, S.

AU - Elman, M. J.

AU - Ballinger, R.

AU - Betancourt, A.

AU - Glasser, D.

AU - Lammlein, J.

PY - 1999/12

Y1 - 1999/12

N2 - 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 rates and risk factors from the study will increase understanding of the clinical course of both conditions, generate hypotheses about etiology, and aid in the design of clinical trials of potential interventions. In addition to collecting natural history data, AREDS includes a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. The clinical trials were initiated largely because of the widespread public use in the United States of commercially 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 include: defining cataract and AMD, estimating event rates, determining the type and dosage of vitamins and minerals to be tested for each condition, and identifying the parameters necessary for monitoring safety and efficacy. This paper describes the AREDS design, including the study rationale and operational structure, and the approach adopted to combine, for two diseases, clinical trials with a natural history study.

AB - 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 rates and risk factors from the study will increase understanding of the clinical course of both conditions, generate hypotheses about etiology, and aid in the design of clinical trials of potential interventions. In addition to collecting natural history data, AREDS includes a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. The clinical trials were initiated largely because of the widespread public use in the United States of commercially 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 include: defining cataract and AMD, estimating event rates, determining the type and dosage of vitamins and minerals to be tested for each condition, and identifying the parameters necessary for monitoring safety and efficacy. This paper describes the AREDS design, including the study rationale and operational structure, and the approach adopted to combine, for two diseases, clinical trials with a natural history study.

KW - Age-related macular degeneration

KW - Antioxidants

KW - Beta-carotene

KW - Cataract

KW - Clinical course

KW - Clinical trial

KW - Vitamin C

KW - Vitamin E

KW - Zinc

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UR - http://www.scopus.com/inward/citedby.url?scp=0033436360&partnerID=8YFLogxK

U2 - 10.1016/S0197-2456(99)00031-8

DO - 10.1016/S0197-2456(99)00031-8

M3 - Article

C2 - 10588299

AN - SCOPUS:0033436360

SN - 0197-2456

VL - 20

SP - 573

EP - 600

JO - Controlled clinical trials

JF - Controlled clinical trials

IS - 6

ER -

The age-related eye disease study (AREDS): Design implications AREDS report no. 1

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Keywords

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