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104. Jahrestagung der Deutschen Ophthalmologischen Gesellschaft 2006
Abstract
Abstract
SA.01.12 The PIER study: Twelve-month efficacy and safety results from a phase III study of ranibizumab 0.3mg and 0.5mg administered initially monthly and then every 3 months for subfoveal choroidal neovascularization secondary to age-related macular degeneration Schmidt-Erfurth U. for the PIER study group
Department of Ophthalmology, Medical University of Vienna Objective: To determine the efficacy and safety of monthly and then quarterly intravitreal injections of ranibizumab 0.3mg or 0.5mg on the durability of treatment effects over two years, as monitored using optical coherence tomography (OCT).
Methods: Patients were randomised 1:1:1 to receive ranibizumab 0.3mg, ranibizumab 0.5mg or sham injection. Inclusion criteria specify a baseline visual acuity (VA) between 20/40 and 20/320. Patients in all arms of the study received three monthly treatments (months 0, 1, 2), and then treatments every three months (months 5, 8, 11, 14, 17, 20, 23). The primary efficacy outcome is mean change in best-corrected visual acuity from baseline, as assessed using ETDRS scores. Secondary endpoints include time to resolution of excess retinal thickness. Safety assessments include the incidence and severity of ocular and non-ocular adverse events over 24 months.
Results: Patients (n=184) with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration with or without a classic lesion component were included into the study. There were no safety concerns noted during the study follow-up of 12 months. An improvement in mean visual acuity is seen in both arms receiving ranibizumab. A reduction in central retinal thickness by OCT is documented reproducibly following retreatment with ranibizumab. The study successfully completed enrolment and all patients completed the 12 month visit in the first quarter of 2006.
Conclusions: The efficacy and safety data from the Phase III PIER trial are essential to provide evidence that a treatment regimen based on less frequent retreatments can result in a similar clinical benefit as previously observed with monthly intravitreal injections of ranibizumab. A reduced retinal thickness by OCT appears to be a reliable parameter for retreatment indication.
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