Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration - Year 1 results of the FOCUS study

Objective: : To investigate the safety and efficacy of intravitreal ranibizumab treatment combined with verteporfin photodynamic therapy ( PDT) in patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration. Methods: In this 2-year, phase I/II, multicenter, randomized, single-masked, controlled study, patients received monthly ranibizumab ( 0.5 mg) ( n=106) or sham ( n=56) injections. The PDT was performed 7 days before initial ranibizumab or sham treatment and then quarterly as needed. Main Outcomes Measures: Proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months ( primary efficacy outcome) and the incidence and severity of adverse events. Results: At 12 months, 90.5% of the ranibizumab-treated patients and 67.9% of the control patients had lost fewer than 15 letters ( P < .001). The most frequent ranibizumab-associated serious ocular adverse events were intraocular inflammation ( 11.4%) and endophthalmitis ( 1.9%; 4.8% if including presumed cases). On average, patients with serious inflammation had better visual acuity outcomes at 12 months than did controls. Key serious nonocular adverse events included myocardial infarctions in the PDT-alone group ( 3.6%) and cerebrovascular accidents in the ranibizumab-treated group ( 3.8%). Conclusion/Application to Clinical Practice: Ranibizumab + PDT was more efficacious than PDT alone for treating neovascular age-related macular degeneration. Although ranibizumab treatment increased the risk of serious intraocular inflammation, affected patients, on average, still experienced visual acuity benefit.