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D.M. Brown, H. Shapiro, S. Schneider, ANCHOR Study Group; Subgroup Analysis of First–Year Results of ANCHOR: A Phase III, Double–Masked, Randomized Comparison of Ranibizumab and Verteporfin Photodynamic Therapy for Predominantly Classic Choroidal Neovascularization Related to Age–Related Macular Degeneration . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2963.
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The ANCHOR study is an ongoing 2–year, Phase III, randomized, multicenter, double–masked clinical trial comparing the efficacy and safety of monthly intravitreal injections of 0.3 or 0.5 mg ranibizumab (LucentisTM) with that of verteporfin (Visudyne®) photodynamic therapy (PDT) in preventing vision loss in predominantly classic choroidal neovascularization (CNV) related to age–related macular degeneration. The main analysis for the primary endpoint_the proportion of patients who at 12 months had lost <15 letters from baseline visual acuity (VA) measured by ETDRS charts_showed that 94.3% receiving 0.3 mg ranibizumab and 96.4% receiving 0.5 mg ranibizumab had maintained VA, versus 64.3% in the PDT group (p <0.0001). This study analyzes this primary endpoint result in select subgroups of the main cohort.
A total of 423 patients were randomized 1:1:1 to receive ranibizumab 0.3 mg plus sham PDT, ranibizumab 0.5 mg plus sham PDT, or PDT plus sham ranibizumab injection. Subgroup analyses were based on age (<75 vs. ≥75 years), gender, baseline VA (≤44 vs. >44 letters), baseline lesion size (≤4 vs. >4 disc areas [DA]), occult CNV (present vs. absent), and prior laser photocoagulation (yes vs. no).
For each subgroup evaluated, the result for the primary endpoint was consistent with that for the overall analysis. Results for the age, gender, and lesion size subgroups are shown below.
Results for the primary endpoint in ANCHOR were highly consistent across subgroups and were consistent with the results of the main analysis.
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