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P. J. Rosenfeld, H. Shapiro, L. Tuomi, M. Webster, J. Elledge, B. Blodi; Lesion Characteristics in Ranibizumab (LUCENTIS®) Treated Patients With a Visual Acuity (VA) Gain or Loss in the MARINA and ANCHOR Trials for Wet Age-Related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2008;49(13):329.
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In the pivotal MARINA and ANCHOR trials of ranibizumab for wet (neovascular) AMD, ranibizumab-treated participants, on average, demonstrated improvement in VA from baseline. In some participants, VA did not improve. A retrospective analysis in patients with >=15 letters loss from baseline VA at month 24 showed that total lesion area increased, although this could not be explained by changes in lesion characteristics attributable to choroidal neovascularization. Further analyses have examined baseline lesion characteristics and their change over time to explore why some patients lose VA while on ranibizumab.
Geographic atrophy (GA) and its proximity to the fovea were retrospectively assessed by the Wisconsin Fundus Photograph Reading Center. These measurements were then compared with the previous fluorescein angiographic (FA) assessments.
In MARINA, mean total area of atrophic scar assessed from FA images changed from baseline by +1.87 disc areas (DA) in VA losers (n=43) vs. +0.52 DA in gainers (n=142) (p=.009). In ANCHOR, mean total area of atrophic scar changed by +0.38 DA in VA losers (n=28) vs. +0.24 DA in gainers (n=105) (p=.46). Changes in GA are shown below.
In MARINA, the mean area of atrophic scar was significantly greater in VA losers than in VA gainers. In both trials, increased area of atrophic scar on angiography did not correlate well with increased GA detected on color photographs. It is important to note that the mean GA growth was within the accepted range for normal disease progression previously reported in AMD.
www.clinicaltrials.gov NCT00061594 and NCT00056836
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