Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
iRORA is measured in μm
Change in Drusen morphology from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen classified as Serous, Reticular or both
Change in Subfoveal drusen area from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Subfoveal drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Change in other drusen area from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Other drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Change in Drusen reflectivity from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen reflectivity classified as a) Low, b) Intermediate, c) High
Change in other Drusen homogeneity from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen homogeneity classified in a) Low b) Intermediate or c) High
Change in ellipsoid zone disruption from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
ellipsoid zone disruption changes classified in a) Yes or b) No
Change in Drusen homogeneity from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen homogeneity classified as a) Homogeneous or b) Heterogeneous
Change in hyperreflective foci from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Hyperreflective foci changes classified in a) Yes or b) No
Change in hyperreflective foci location (within 500-μm disc area) from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
hyperreflective foci location (within 500-μm disc area) changes classified as a) Yes or b) No
Change in hyperreflective foci association to drusen from baseline
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
hyperreflective foci association to drusen from baseline classified as a) Yes or b) No
Progression to Moderate Vision Loss
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
Geographic Atrophy (GA) Growth Rate
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
The annual growth rate of GA or nascent GA area measured in square root transform of the area measured in mm2 (final values in mm), based on SD-OCT Spectralis Heidelberg