AIM： To assess the effectiveness and safety of ranibizumab 0.5 mg in Taiwan Residents patients with polypoidal choroidal vasculopathy（PCV） by performing a retrospective exploratory subgroup analysis of the REAL stu...AIM： To assess the effectiveness and safety of ranibizumab 0.5 mg in Taiwan Residents patients with polypoidal choroidal vasculopathy（PCV） by performing a retrospective exploratory subgroup analysis of the REAL study.METHODS： REAL was a 12-month, observational, prospective, non-interventional phase IV post-marketing surveillance study conducted at 9 centers in Taiwan. The study collected data as part of the routine patient visits from the medical records of patients with neovascular agerelated macular degeneration treated with ranibizumab 0.5 mg according to local standard medical practice and local label and/or reimbursement guidelines. The presence of PCV at baseline was determined using indocy received prior tanine green angiography. RESULTS： At baseline, PCV was diagnosed in 64 of the 303 enrolled patients（21.1%）. Of these, 41 patients（64.1%） hadreatment; 15（23.4%） patients had received ranibizumab. The intent-to-treat population included 58 patients; 47（80%） who received ranibizumab and 11（20%） who received ranibizumab plus photodynamic therapy（PDT; 9 patients received once, 2 patients received twice）. Bevacizumab was used as a concomitant medication in a similar percentage of patients who received ranibizumab（43%, n=20） or ranibizumab plus PDT（45%, n=5）. In patients who received ranibizumab, visual acuity（VA） at baseline was 50.1±12.9 Early Treatment Diabetic Retinopathy Study letters, and the gain at month 12 was 1.1±17.8 letters. In patients who received ranibizumab plus PDT, VA at baseline was 51.4±15.9 letters, and there was a marked gain in VA at month 12（14.0±9.2 letters, P=0.0009）. In the intent-totreat population, the reduction in central retinal subfield thickness from baseline at month 12 was 69.6±122.6 μm（baseline： 310.8±109.8 μm, P=0.0004）. The safety results were consistent with the well-characterized safety profile of ranibizumab.CONCLUSION： In real-world settings, ranibizumab 0.5 mg treatment for 12 mo results in maintenance of VA and reduction in central retinal subfield thickness in Taiwan Residents patients with PCV. Improvements in VA are observed in patients who received ranibizumab plus PDT. There are no new safety findings.展开更多
文摘AIM： To assess the effectiveness and safety of ranibizumab 0.5 mg in Taiwan Residents patients with polypoidal choroidal vasculopathy（PCV） by performing a retrospective exploratory subgroup analysis of the REAL study.METHODS： REAL was a 12-month, observational, prospective, non-interventional phase IV post-marketing surveillance study conducted at 9 centers in Taiwan. The study collected data as part of the routine patient visits from the medical records of patients with neovascular agerelated macular degeneration treated with ranibizumab 0.5 mg according to local standard medical practice and local label and/or reimbursement guidelines. The presence of PCV at baseline was determined using indocy received prior tanine green angiography. RESULTS： At baseline, PCV was diagnosed in 64 of the 303 enrolled patients（21.1%）. Of these, 41 patients（64.1%） hadreatment; 15（23.4%） patients had received ranibizumab. The intent-to-treat population included 58 patients; 47（80%） who received ranibizumab and 11（20%） who received ranibizumab plus photodynamic therapy（PDT; 9 patients received once, 2 patients received twice）. Bevacizumab was used as a concomitant medication in a similar percentage of patients who received ranibizumab（43%, n=20） or ranibizumab plus PDT（45%, n=5）. In patients who received ranibizumab, visual acuity（VA） at baseline was 50.1±12.9 Early Treatment Diabetic Retinopathy Study letters, and the gain at month 12 was 1.1±17.8 letters. In patients who received ranibizumab plus PDT, VA at baseline was 51.4±15.9 letters, and there was a marked gain in VA at month 12（14.0±9.2 letters, P=0.0009）. In the intent-totreat population, the reduction in central retinal subfield thickness from baseline at month 12 was 69.6±122.6 μm（baseline： 310.8±109.8 μm, P=0.0004）. The safety results were consistent with the well-characterized safety profile of ranibizumab.CONCLUSION： In real-world settings, ranibizumab 0.5 mg treatment for 12 mo results in maintenance of VA and reduction in central retinal subfield thickness in Taiwan Residents patients with PCV. Improvements in VA are observed in patients who received ranibizumab plus PDT. There are no new safety findings.
