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Nicolas Leveziel, Adnan Tufail, Hyeong Gon Yu, You-xin Chen, Frank G Holz, Claudia Leteneux, Stefan Pilz, ; Ranibizumab treatment outcome in visual impairment due to myopic choroidal neovascularization: RADIANCE subgroup analysis based on baseline ocular characteristics. Invest. Ophthalmol. Vis. Sci. 2014;55(13):4956.
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The RADIANCE study evaluated the efficacy and safety of two different ranibizumab 0.5 mg regimens versus verteporfin photodynamic therapy (vPDT) in patients with visual impairment due to myopic choroidal neovascularization (CNV). Both ranibizumab regimens were superior to vPDT at Month 3 (primary endpoint was met) and were effective in improving and sustaining best-corrected visual acuity (BCVA) over 12 months. In a post-hoc analysis, the baseline ocular conditions and the associated exposure and treatment benefits with respect to BCVA were explored in patients who received ranibizumab retreatment, guided by disease activity criteria according to the approved ranibizumab label for treatment of visual impairment due to CNV secondary to pathologic myopia (myopic CNV).
Patients (N=277) were randomized 2:2:1 to Group (G) 1 (ranibizumab treatment guided by VA stabilization), G2 (ranibizumab treatment guided by disease activity), or G3 ( vPDT and as of Month 3, ranibizumab and/or vPDT at investigator’s discretion). BCVA outcomes and treatment exposure of G2 were analyzed by descriptive statistics for the following baseline categories: lesion area (<1.3mm2/1.3-<3.4mm2/≥3.4mm2); CNV lesion area (<0.8mm2/0.8-<2.4mm2/≥2.4mm2); refraction sphere (<10 diopters [D]/10-<20D/≥20D) and axial length (<28mm/28-<30mm/≥30mm). The main outcomes were mean change in BCVA from baseline and number of injections up to M12.
Ranibizumab treatment led to BCVA improvement across the subgroups analyzed. The BCVA outcomes observed in the subgroups at month 12 were in accordance with that of the overall study population. Mean change in BCVA from baseline and the median numbers of injections received at Month12 are presented in Table 1
Ranibizumab treatment was effective in improving the BCVA outcomes in all the subgroups. Regardless of the severity of myopic CNV at baseline, the BCVA gains observed at Month 12 were similar across the subgroups to the overall study population, while there was an inter individual variability in the number of injections required to achieve these outcomes
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