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J.W. Miller, H. Shapiro, N. Acharya, for the MARINA Study Group; Randomized, Controlled Phase III Study of Ranibizumab (LucentisTM) for Minimally Classic or Occult Neovascular Age–Related Macular Degeneration: Two–Year Safety Results of the MARINA Study . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3539.
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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.
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). Safety outcome measures included the incidence and severity of ocular and nonocular adverse events and changes in vital signs.
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). First–year safety results indicated that patients treated with repeated ranibizumab injections had a low rate of serious ocular adverse events (<1% each), including endophthalmitis, uveitis, retinal detachment, retinal tear, vitreous hemorrhage, and lens damage. No notable imbalance in nonocular adverse events was observed. 683 patients (95%) commenced the second year of the study and were followed for safety and efficacy outcomes. For the final 3 months (October – December 2005), all patients initially randomized to sham injection were crossed over to treatment with 0.5 mg ranibizumab. The last 24–month follow–up visit is anticipated in December 2005, with subsequent data analysis.
One–year data from the MARINA trial showed that ranibizumab was well tolerated with a low rate of serious ocular and systemic adverse events. Two–year safety results will be presented.
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