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- Title
Association of 2-Year Progression Along the AREDS AMD Scale and Development of Late Age-Related Macular Degeneration or Loss of Visual Acuity: AREDS Report 41.
- Authors
Vitale, Susan; Agrón, Elvira; Clemons, Traci E.; Keenan, Tiarnan D. L.; Domalpally, Amitha; Danis, Ronald P.; Chew, Emily Y.; Danis, Ronald P Jr
- Abstract
<bold>Importance: </bold>The Age-Related Eye Disease Study age-related macular degeneration (AREDS AMD) scale is designed to classify AMD severity. The present cohort study explored whether 2-year progression along this scale was useful for estimating the risk of future progression to late AMD or best-corrected visual acuity (BCVA) loss.<bold>Objective: </bold>To assess whether 2-year progression along the AREDS AMD scale can be used to estimate the probability of long-term clinically meaningful outcome measures for clinical trials or epidemiologic studies.<bold>Design, Setting, and Participants: </bold>Age-Related Eye Disease Study participants enrolled in a clinical trial of oral micronutrient supplements had annual color fundus photographs graded centrally using the AREDS AMD scale. Two-year progression (≥2-step and ≥3-step increases in AMD score between baseline and the 2-year study visit) was evaluated as a method of estimating the risk of long-term progression to late AMD or BCVA loss. The AREDS (1992-2001) was a randomized, placebo-controlled clinical trial based at 11 retinal specialty clinics in the United States. The dates of analysis in the present cohort study were November 1992 through November 2005.<bold>Main Outcomes and Measures: </bold>Development of neovascular (NV) AMD, central geographic atrophy (CGA), any geographic atrophy (GA), or BCVA loss of at least 2 lines or at least 3 lines.<bold>Results: </bold>Among 3868 participants in the AREDS free of late AMD at baseline, the mean (SD) age was 68.3 (5.0) years, and 2180 of 3868 (56.4%) were women. In the first 2 years after randomization to the AREDS, 669 of 7458 (9.0%) of eyes had at least 2-step 2-year progression, and 275 of 7458 (3.7%) of eyes had at least 3-step 2-year progression. In the 5-year follow-up period (years 2-7), 486 of 7223 (6.7%) of eyes developed NV AMD, 339 of 7253 (4.7%) developed CGA, 726 of 7246 (10.0%) developed any GA, 2622 of 7095 (37.0%) had at least 2-line BCVA loss, and 1494 of 7155 (20.9%) had at least 3-line BCVA loss. After adjusting for demographic and clinical confounders and stratifying by baseline AMD score, statistically significant associations were observed between at least 2-step and at least 3-step 2-year progression of AMD score and subsequent 5-year development of NV AMD: hazard ratios (HRs) ranged from 3.6 (99% CI, 2.4-5.2) to 19.4 (99% CI, 7.7-48.9). For CGA, HRs ranged from 2.6 (99% CI, 1.7-4.0) to 4.7 (99% CI, 2.5-8.9); the results were similar for any GA. For at least 2-line and at least 3-line BCVA loss, HRs ranged from 1.3 (99% CI, 1.0-1.7) to 2.8 (99% CI, 1.8-4.3). For all outcomes, at least 3-step 2-year progression had stronger associations than at least 2-step 2-year progression. These findings were also validated in the AREDS2 cohort.<bold>Conclusions and Relevance: </bold>Two-year progression of AMD score was associated with progression to clinically meaningful anatomic (late AMD) and vision (≥2-line or ≥3-line loss) outcomes, suggesting that this scale may be useful for future clinical trials designed to slow the progression of AMD.
- Subjects
THERAPEUTIC use of antioxidants; DISEASE progression; RESEARCH; RETINA; RETINAL degeneration; TIME; RESEARCH methodology; PROGNOSIS; RETROSPECTIVE studies; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; VISUAL acuity; LONGITUDINAL method; EYE examination
- Publication
JAMA Ophthalmology, 2020, Vol 138, Issue 6, p610
- ISSN
2168-6165
- Publication type
journal article
- DOI
10.1001/jamaophthalmol.2020.0824