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104. Jahrestagung der Deutschen Ophthalmologischen Gesellschaft 2006
Abstract
Abstract
DO.02.03 Randomized, controlled phase III study of Ranibizumab (LucentisTM) for minimally classic or occult neovascular age-related macular degeneration: Two-year efficacy and safety results of the MARINA study Holz F. G. for the MARINA-Study Group
Department of Ophthalmology, University of Bonn Objective: Ranibizumab (LucentisTM) is a humanized antigen-binding antibody fragment (Fab) that binds to and neutralizes all active forms of vascular endothelial growth factor-A. The MARINA study is a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of monthly intravitreal injections of ranibizumab in treating patients with minimally classic or occult choroidal neovascularization secondary to age-related macular degeneration.
Methods: A total of 716 participants were randomized in a 1:1:1 ratio to receive 0.5 mg of ranibizumab, 0.3 mg of ranibizumab, or a sham injection monthly for 2 years of treatment (24 injections). Efficacy outcome measures at 24 months are the proportions of patients losing <15 letters or gaining ³15 letters from baseline in best corrected VA score (measured by a standardized protocol refraction using ETDRS charts), mean change from baseline VA, proportion of patients with a VA Snellen equivalent of 20/200 or worse, and mean changes from baseline in the total area of CNV and total area of leakage from CNV.
Results: The study met the primary efficacy endpoint at 1 year, with nearly 95% of subjects receiving 0.3 or 0.5 mg ranibizumab losing <15 letters of visual acuity versus 62% of sham-injected patients (P<0.0001, each dose). 683 of the 716 randomized patients (95%) started the second year. At 2 years 92% of subjects receiving 0.3 mg and 90% of subjects 0.5 mg ranibizumab lost <15 letters of VA versus 53% of sham-injected patients (P<0.0001). The proportion of subjects gaining ³15 letters from baseline was 26% (0.3 mg ranibizumab) and 33% (0.5mg ranibizumab) vs. 4% in the sham group. Over 70% of ranibizumab-treated patients had VA scores above those at baseline at 24 months.
Conclusions: Two-year data from the MARINA trial show that ranibizumab prevents vision loss, and in many patients improved vision. Two-year safety data confirm that ocular severe adverse events are uncommon and that there is no evidence for systemic side effects of intravitreally administered ranibizumab.
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