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J. S. Heier, III, C. Chung, S. Schneider, ANCHOR Study Group; Time Course of Visual Acuity Changes With Ranibizumab (LucentisTM) in the 2-Year ANCHOR Study of Patients with Neovascular Age-Related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2007;48(13):2872.
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Ranibizumab (LucentisTM) is a humanized antigen-binding antibody fragment (Fab) that binds to and neutralizes all known active forms of vascular endothelial growth factor-A (VEGF-A). First-year results of the 2-year ANCHOR study in patients with predominantly classic choroidal neovascularization secondary to AMD showed that intravitreal treatment with ranibizumab was well tolerated and superior to verteporfin photodynamic therapy (PDT) in preventing further visual acuity (VA) loss, and that ranibizumab-treated patients, on average, gained VA. We will report the time course of VA changes during both years of ANCHOR.
In this Phase III, randomized, multicenter, double-masked trial, 423 patients were randomized 1:1:1 to ranibizumab 0.3 mg + sham PDT, ranibizumab 0.5 mg + sham PDT, or PDT + sham ranibizumab injection. Ranibizumab (or sham) injection was administered monthly; PDT (or sham) was administered at study day 0 and then quarterly as needed. Key VA outcomes in the primary analysis at 1 year were the proportion of patients losing <15 letters from baseline, the proportion gaining ≥15 letters from baseline, and mean change from baseline. These outcomes continued to be measured through the second year.
During the first year of ANCHOR, the superiority of ranibizumab to PDT was evident by 1 month following the initial treatment and increased over time throughout 12 months. Some patients whose response to ranibizumab treatment by month 3 was a decrease in VA ended up having some letter gain or even a gain of 15 or more letters compared with baseline by month 12. The second-year results were not yet available at the deadline for abstract submission.
Analysis of the time course of VA outcomes during the first year of ANCHOR indicates that the mean VA benefit of ranibizumab compared with PDT was evident after the first month of treatment, but that even patients who did not show this early benefit might respond later in the course of their treatment. Time course results incorporating the second year of treatment will be presented.
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