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Original Investigation | Journal Club

Evaluating the Validity of the Age-Related Eye Disease Study Grading Scale for Age-Related Macular Degeneration AREDS2 Report 10

Susan Vitale, PhD, MHS1; Traci E. Clemons, PhD2; Elvira Agrón, MA1; Frederick L. Ferris III, MD1; Amitha Domalpally, MD3; Ronald P. Danis, MD3; Emily Y. Chew, MD1 ; for the Age-Related Eye Disease Study 2 (AREDS2) Research Group
[+] Author Affiliations
1Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland
2EMMES Corporation, Rockville, Maryland
3Fundus Photograph Reading Center, University of Wisconsin, Madison
JAMA Ophthalmol. 2016;134(9):1041-1047. doi:10.1001/jamaophthalmol.2016.2383.
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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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Figures

Place holder to copy figure label and caption
Figure 1.
Comparing Rates of Progression to Late Age-Related Macular Degeneration (AMD) (Neovascular AMD, Central Geographic Atrophy, or Both) in the Age-Related Eye Disease Study (AREDS) and AREDS2

The numbers above each bar are the numbers at risk in that category.

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Figure 2.
Five-Year Rates of Progression to Late Neovascular (NV) Age-Related Macular Degeneration (AMD) in the Age-Related Eye Disease Study 2 (AREDS2) Stratified by Status of Fellow Eye at Baseline

The numbers above each bar are the numbers at risk in that category.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 3.
Five-Year Rates of Age-Related Macular Degeneration (AMD) Progression in Persons Free of Late AMD at Baseline for the Age-Related Eye Disease Study (AREDS) and AREDS2

Five-year progression rates to stages 7 to 9 and to late AMD and 5-year progression rates to neovascular (NV) AMD only and to central geographic atrophy (GA) only are shown. The numbers above each bar are the numbers at risk in that category.

Graphic Jump Location

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