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Emily Y Chew, Elvira Agron, Traci E Clemons, Amitha Domalpally, Ronald P Danis; Progression of Geographic Atrophy in the Age-Related Eye Disease Study 2 (AREDS2). Invest. Ophthalmol. Vis. Sci. 201657(12):.
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© ARVO (1962-2015); The Authors (2016-present)
Due to the lack of proven therapies, geographic atrophy (GA) associated with age-related macular degeneration (AMD), the leading cause of blindness in the developed world, remains an unmet medical need. Evaluation of the outcome measurements for the numerous clinical trials underway to test potential therapies for GA is essential. The purpose of this study is to evaluate the progression rate of GA in the Age-Related Eye Disease Study 2 (AREDS2) using color fundus photograph (CFP) and/or fundus autofluorescence (FAF).
AREDS2 was a randomized clinical trial of oral supplements for the treatment of AMD. Stereoscopic CFP and FAF images were obtained at baseline and annually and graded at the reading center, using standardized protocol. GA was defined on CFP as an area of ≧430 microns in diameter with sharp borders and lacking retinal pigment epithelium. FAF was defined as a lesion of hypofluorescence (similar to the optic disk) of ≧420 microns in diameter. Areas of GA were measured with computer planimetry. The rates of progression and the correlation of the two modalities were evaluated, using square root transformation. Configuration of lesions were evaluated as unifocal or multi-focal.
421 (527 eyes) participants had GA at baseline. While 935 (1165 eyes) developed GA during the course of the study, 619 (527 eyes) had at least 2 additional visits following baseline were analyzed. The rates of progression of both prevalent and incident GA similar to that found in AREDS. More eyes with GA were identified by FAF than CFP. There is overall good agreement between FAF and CFP for detecting GA (kappa=0.79) and detecting foveal involvement (kappa=0.72). The growth rate of GA for multi-focal lesions was lower than that of the unifocal lesions.
FAF and CFP have general good agreement for assessing progression of GA while FAF identified slightly larger area of GA than CFP. FAF also was more sensitive for smaller loci of GA. The use of both FAF and CFP complement each other and both may be important in identifying foveal involvement with GA. The configuration of GA may also play a role in progression rate of GA. These data may help the planning of future studies of GA associated with AMD.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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