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T. A. Ciulla, H. Shapiro, S. Schneider, MARINA and ANCHOR Study Groups; Ranibizumab (LucentisTM) for Neovascular Age-Related Macular Degeneration (AMD): 1-Year Visual Acuity (VA) Results for Fellow Eyes With Neovascular AMD in MARINA and ANCHOR. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4573.
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In the pivotal MARINA and ANCHOR trials, monthly intravitreal injections of ranibizumab in patients with choroidal neovascularization (CNV) secondary to AMD prevented further VA loss or improved VA on average in treated eyes. Only one eye per patient received study treatment. Fellow eyes with AMD received usual care, excluding anti-VEGF drugs. We reviewed data in these 2 pivotal trials to assess any effect of ranibizumab treatment of study eyes on VA in fellow eyes with neovascular AMD.
716 MARINA and 423 ANCHOR participants were randomized 1:1:1, double-masked, to 0.5 mg ranibizumab, 0.3 mg ranibizumab, or control treatment (sham injection or verteporfin photodynamic therapy [PDT], respectively). Fellow eyes with neovascular AMD (any CNV angiographic type) were assessed using Early Treatment Diabetic Retinopathy Study charts at month 12 for loss of <15 letters, gain of ≥ 15 letters, and mean change from baseline VA. The last observation was used for missing month 12 assessments.
In MARINA, mean baseline VA (letters) was 35.5 for sham (n=101), 34.2 for 0.3 mg ranibizumab (n=112), and 36.2 for 0.5 mg ranibizumab (n=116) (approx. Snellen equivalents: 20/200). Respectively, 88%, 85%, and 93% of patients lost <15 letters; 7%, 8%, and 11% gained ≥15 letters; mean change was -0.9, -1.0, and +2.0 letters.In ANCHOR, mean baseline VA (letters) was 36.4 for PDT (n=60), 26.9 for 0.3 mg ranibizumab (n=49), and 36.9 for 0.5 mg ranibizumab (n=43) (approx. Snellen equivalents: 20/200, 20/320, and 20/200, respectively). Respectively, 90%, 88%, and 88% of patients lost <15 letters; 8%, 10%, and 14% gained ≥15 letters; mean change was -0.2, 0.0, and -1.1 letters.These differences between ranibizumab and control were not statistically significant in either study.
For fellow eyes with neovascular AMD, 1-year data from the MARINA and ANCHOR trials showed relatively stable VA over time in all treatment groups. A trend toward a potential VA benefit of 0.5 mg ranibizumab over sham in MARINA warrants further study.
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