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J.S. Heier, H. Shapiro, A.A. Singh, Sr., MARINA Study Group; Randomized, Controlled Phase III Study of Ranibizumab (LucentisTM) for Minimally Classic or Occult Neovascular Age–Related Macular Degeneration: Two–Year Efficacy Results of the MARINA Study . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2959.
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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). Efficacy outcome measures at 24 months are the proportions of patients losing <15 letters or gaining ≥ 15 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.
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. For the final 3 months of the study (October – December 2005), all patients 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 prevented vision loss, and in many patients improved vision. Two–year efficacy results will be presented.
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