Evaluating the validity of the age-related eye disease study grading scale for age-related macular degeneration AREDS2 report 10

Susan Vitale, Traci E. Clemons, Elvira Agrón, Frederick L. Ferris, Amitha Domalpally, Ronald P. Danis, Emily Y. Chew

Research output: Contribution to journalArticle

Abstract

IMPORTANCE To test potential treatments for age-related macular degeneration (AMD), clinical trials need standardized outcome measures that are valid for predicting AMD progression in different study populations. OBJECTIVE To evaluate the validity of the Age-Related Eye Disease Study (AREDS) detailed and simple AMD severity scales by comparing rates of development of late AMD (neovascular AMD and/or central geographic atrophy) between AREDS and AREDS2 participants. DESIGN, SETTING, AND PARTICIPANTS Both AREDS (1992-2001) and AREDS2 (2006-2012) enrolled patients from academic and community-based retinal practices across the United States. In AREDS (n = 4519), participants with varying severity of AMD-from no AMD to late AMD in 1 eye-were enrolled. In AREDS2 (n = 4203), participants with bilateral large drusen or large drusen in the study eye and late AMD in the fellow eye were enrolled. MAIN OUTCOMES AND MEASURES Five-year incidence of late AMD, assessed by annual masked centralized fundus photograph grading. RESULTS In AREDS, the mean (SD) age of the patients was 69.3 (5.7) years, and 2519 (55.7%) were female. In AREDS2, the mean (SD) age of the patients was 73.1 (7.7) years, and 2388 (56.8%) were female. The 5-year rates of late AMD did not differ between AREDS2 and AREDS participants within nearly all baseline AMD detailed severity scale levels: Levels 1 to 3: 2.4%vs 0.5%(difference, 1.9%; 95%CI, -0.2%to 4.0%; P < .001); level 4: 6.5%vs 4.9% (difference, 1.6%; 95%CI, -1.7%to 4.8%; P = .34); level 5: 8.0%vs 5.6%(difference, 2.4%; 95%CI, -1.2%to 5.9%; P = .22); level 6: 12.8%vs 13.7%(difference, -0.9%; 95%CI, -4.8% to 3.1%; P = .66); level 7: 26.2%vs 27.8%(difference, -1.5%; 95%CI, -6.6%to 3.5%; P = .54); and level 8: 46.4%vs 44.7%(difference, 1.7%; 95%CI, -7.5%to 10.9%; P = .72). Within simple scale levels, AREDS2 and AREDS 5-year rates did not differ significantly except for level 1 (9.4%vs 3.1%, P = .02; level 2: 12.8%vs 11.8%, P = .65; level 3: 26.3%vs 25.9%, P = .90; and level 4: 45.6%vs 47.3%, P = .57). CONCLUSIONS AND RELEVANCE The AREDS detailed and simple AMD severity scales were useful measures for assessing the risk of developing late AMD in the AREDS2 population; these data suggest that they should be useful tools for clinical trials of AMD treatments.

Original languageEnglish (US)
Pages (from-to)1041-1047
Number of pages7
JournalJAMA Ophthalmology
Volume134
Issue number9
DOIs
StatePublished - Sep 1 2016
Externally publishedYes

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Eye Diseases
Macular Degeneration
Geographic Atrophy
Clinical Trials
Population

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Vitale, S., Clemons, T. E., Agrón, E., Ferris, F. L., Domalpally, A., Danis, R. P., & Chew, E. Y. (2016). Evaluating the validity of the age-related eye disease study grading scale for age-related macular degeneration AREDS2 report 10. JAMA Ophthalmology, 134(9), 1041-1047. https://doi.org/10.1001/jamaophthalmol.2016.2383

Evaluating the validity of the age-related eye disease study grading scale for age-related macular degeneration AREDS2 report 10. / Vitale, Susan; Clemons, Traci E.; Agrón, Elvira; Ferris, Frederick L.; Domalpally, Amitha; Danis, Ronald P.; Chew, Emily Y.

In: JAMA Ophthalmology, Vol. 134, No. 9, 01.09.2016, p. 1041-1047.

Research output: Contribution to journalArticle

Vitale, Susan ; Clemons, Traci E. ; Agrón, Elvira ; Ferris, Frederick L. ; Domalpally, Amitha ; Danis, Ronald P. ; Chew, Emily Y. / Evaluating the validity of the age-related eye disease study grading scale for age-related macular degeneration AREDS2 report 10. In: JAMA Ophthalmology. 2016 ; Vol. 134, No. 9. pp. 1041-1047.
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abstract = "IMPORTANCE To test potential treatments for age-related macular degeneration (AMD), clinical trials need standardized outcome measures that are valid for predicting AMD progression in different study populations. OBJECTIVE To evaluate the validity of the Age-Related Eye Disease Study (AREDS) detailed and simple AMD severity scales by comparing rates of development of late AMD (neovascular AMD and/or central geographic atrophy) between AREDS and AREDS2 participants. DESIGN, SETTING, AND PARTICIPANTS Both AREDS (1992-2001) and AREDS2 (2006-2012) enrolled patients from academic and community-based retinal practices across the United States. In AREDS (n = 4519), participants with varying severity of AMD-from no AMD to late AMD in 1 eye-were enrolled. In AREDS2 (n = 4203), participants with bilateral large drusen or large drusen in the study eye and late AMD in the fellow eye were enrolled. MAIN OUTCOMES AND MEASURES Five-year incidence of late AMD, assessed by annual masked centralized fundus photograph grading. RESULTS In AREDS, the mean (SD) age of the patients was 69.3 (5.7) years, and 2519 (55.7{\%}) were female. In AREDS2, the mean (SD) age of the patients was 73.1 (7.7) years, and 2388 (56.8{\%}) were female. The 5-year rates of late AMD did not differ between AREDS2 and AREDS participants within nearly all baseline AMD detailed severity scale levels: Levels 1 to 3: 2.4{\%}vs 0.5{\%}(difference, 1.9{\%}; 95{\%}CI, -0.2{\%}to 4.0{\%}; P < .001); level 4: 6.5{\%}vs 4.9{\%} (difference, 1.6{\%}; 95{\%}CI, -1.7{\%}to 4.8{\%}; P = .34); level 5: 8.0{\%}vs 5.6{\%}(difference, 2.4{\%}; 95{\%}CI, -1.2{\%}to 5.9{\%}; P = .22); level 6: 12.8{\%}vs 13.7{\%}(difference, -0.9{\%}; 95{\%}CI, -4.8{\%} to 3.1{\%}; P = .66); level 7: 26.2{\%}vs 27.8{\%}(difference, -1.5{\%}; 95{\%}CI, -6.6{\%}to 3.5{\%}; P = .54); and level 8: 46.4{\%}vs 44.7{\%}(difference, 1.7{\%}; 95{\%}CI, -7.5{\%}to 10.9{\%}; P = .72). Within simple scale levels, AREDS2 and AREDS 5-year rates did not differ significantly except for level 1 (9.4{\%}vs 3.1{\%}, P = .02; level 2: 12.8{\%}vs 11.8{\%}, P = .65; level 3: 26.3{\%}vs 25.9{\%}, P = .90; and level 4: 45.6{\%}vs 47.3{\%}, P = .57). CONCLUSIONS AND RELEVANCE The AREDS detailed and simple AMD severity scales were useful measures for assessing the risk of developing late AMD in the AREDS2 population; these data suggest that they should be useful tools for clinical trials of AMD treatments.",
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T1 - Evaluating the validity of the age-related eye disease study grading scale for age-related macular degeneration AREDS2 report 10

AU - Vitale, Susan

AU - Clemons, Traci E.

AU - Agrón, Elvira

AU - Ferris, Frederick L.

AU - Domalpally, Amitha

AU - Danis, Ronald P.

AU - Chew, Emily Y.

PY - 2016/9/1

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N2 - IMPORTANCE To test potential treatments for age-related macular degeneration (AMD), clinical trials need standardized outcome measures that are valid for predicting AMD progression in different study populations. OBJECTIVE To evaluate the validity of the Age-Related Eye Disease Study (AREDS) detailed and simple AMD severity scales by comparing rates of development of late AMD (neovascular AMD and/or central geographic atrophy) between AREDS and AREDS2 participants. DESIGN, SETTING, AND PARTICIPANTS Both AREDS (1992-2001) and AREDS2 (2006-2012) enrolled patients from academic and community-based retinal practices across the United States. In AREDS (n = 4519), participants with varying severity of AMD-from no AMD to late AMD in 1 eye-were enrolled. In AREDS2 (n = 4203), participants with bilateral large drusen or large drusen in the study eye and late AMD in the fellow eye were enrolled. MAIN OUTCOMES AND MEASURES Five-year incidence of late AMD, assessed by annual masked centralized fundus photograph grading. RESULTS In AREDS, the mean (SD) age of the patients was 69.3 (5.7) years, and 2519 (55.7%) were female. In AREDS2, the mean (SD) age of the patients was 73.1 (7.7) years, and 2388 (56.8%) were female. The 5-year rates of late AMD did not differ between AREDS2 and AREDS participants within nearly all baseline AMD detailed severity scale levels: Levels 1 to 3: 2.4%vs 0.5%(difference, 1.9%; 95%CI, -0.2%to 4.0%; P < .001); level 4: 6.5%vs 4.9% (difference, 1.6%; 95%CI, -1.7%to 4.8%; P = .34); level 5: 8.0%vs 5.6%(difference, 2.4%; 95%CI, -1.2%to 5.9%; P = .22); level 6: 12.8%vs 13.7%(difference, -0.9%; 95%CI, -4.8% to 3.1%; P = .66); level 7: 26.2%vs 27.8%(difference, -1.5%; 95%CI, -6.6%to 3.5%; P = .54); and level 8: 46.4%vs 44.7%(difference, 1.7%; 95%CI, -7.5%to 10.9%; P = .72). Within simple scale levels, AREDS2 and AREDS 5-year rates did not differ significantly except for level 1 (9.4%vs 3.1%, P = .02; level 2: 12.8%vs 11.8%, P = .65; level 3: 26.3%vs 25.9%, P = .90; and level 4: 45.6%vs 47.3%, P = .57). CONCLUSIONS AND RELEVANCE The AREDS detailed and simple AMD severity scales were useful measures for assessing the risk of developing late AMD in the AREDS2 population; these data suggest that they should be useful tools for clinical trials of AMD treatments.

AB - IMPORTANCE To test potential treatments for age-related macular degeneration (AMD), clinical trials need standardized outcome measures that are valid for predicting AMD progression in different study populations. OBJECTIVE To evaluate the validity of the Age-Related Eye Disease Study (AREDS) detailed and simple AMD severity scales by comparing rates of development of late AMD (neovascular AMD and/or central geographic atrophy) between AREDS and AREDS2 participants. DESIGN, SETTING, AND PARTICIPANTS Both AREDS (1992-2001) and AREDS2 (2006-2012) enrolled patients from academic and community-based retinal practices across the United States. In AREDS (n = 4519), participants with varying severity of AMD-from no AMD to late AMD in 1 eye-were enrolled. In AREDS2 (n = 4203), participants with bilateral large drusen or large drusen in the study eye and late AMD in the fellow eye were enrolled. MAIN OUTCOMES AND MEASURES Five-year incidence of late AMD, assessed by annual masked centralized fundus photograph grading. RESULTS In AREDS, the mean (SD) age of the patients was 69.3 (5.7) years, and 2519 (55.7%) were female. In AREDS2, the mean (SD) age of the patients was 73.1 (7.7) years, and 2388 (56.8%) were female. The 5-year rates of late AMD did not differ between AREDS2 and AREDS participants within nearly all baseline AMD detailed severity scale levels: Levels 1 to 3: 2.4%vs 0.5%(difference, 1.9%; 95%CI, -0.2%to 4.0%; P < .001); level 4: 6.5%vs 4.9% (difference, 1.6%; 95%CI, -1.7%to 4.8%; P = .34); level 5: 8.0%vs 5.6%(difference, 2.4%; 95%CI, -1.2%to 5.9%; P = .22); level 6: 12.8%vs 13.7%(difference, -0.9%; 95%CI, -4.8% to 3.1%; P = .66); level 7: 26.2%vs 27.8%(difference, -1.5%; 95%CI, -6.6%to 3.5%; P = .54); and level 8: 46.4%vs 44.7%(difference, 1.7%; 95%CI, -7.5%to 10.9%; P = .72). Within simple scale levels, AREDS2 and AREDS 5-year rates did not differ significantly except for level 1 (9.4%vs 3.1%, P = .02; level 2: 12.8%vs 11.8%, P = .65; level 3: 26.3%vs 25.9%, P = .90; and level 4: 45.6%vs 47.3%, P = .57). CONCLUSIONS AND RELEVANCE The AREDS detailed and simple AMD severity scales were useful measures for assessing the risk of developing late AMD in the AREDS2 population; these data suggest that they should be useful tools for clinical trials of AMD treatments.

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