First Author: A.Tufail UK
Co Author(s): Y.X. Chen H. Gon Yu N. Leveziel C. Leteneux S. Pilz F. G. Holz 0 0 0 0 0 0 0 0 0
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Ranibizumab 0.5mg is approved for the treatment of visual impairment(VI) due to choroidal neovascularization(CNV) secondary to pathologic myopia(myopic CNV). In RADIANCE, individualized ranibizumab treatment was superior to verteporfin photodynamic therapy(vPDT) in terms of visual acuity(VA). Ranibizumab improved mean VA by 14.4 letters with a median of two injections at month 12 (disease activity treatment group, basis for label) and was generally well tolerated. Here, we report results of a post-hoc subgroup analysis that explored whether VA outcome and treatment exposure in the overall RADIANCE population is consistent in subgroups of patients with different baseline ocular characteristics.
A post-hoc subgroup analysis of 12 month data from the RADIANCE study. RADIANCE was a Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study in patients with VI due to myopic CNV.
In the RADIANCE study, patients (N=277) were randomized 2:2:1 to Group 1 (ranibizumab treatment guided by VA stabilization), Group 2 (ranibizumab treatment guided by disease activity), or Group 3 (vPDT and as of Month 3, ranibizumab and/or vPDT at investigators' discretion). This subgroup analysis was confined to Group 2 patients, which was the basis for the approved ranibizumab label for treatment of visual impairment due to myopic CNV. At month 12, the mean change in BCVA from baseline and number of injections were compared according to the following baseline ocular characteristics [number of patients, n]: lesion area, mm2 (<1.3 [n=36]/1.3-<3.4 [n=52]/≥3.4 [n=21]); CNV lesion area, mm2 (<0.8 [n=31]/0.8-<2.4 [n=58]/≥2.4 [n=18]); refraction sphere, diopters (<10 [n=49]/10-<20 [n=60]/≥20 [n=7]), axial length, mm (<28 [n=44]/28-<30 [n=38]/≥30 [n=34]).
In RADIANCE, the ranibizumab retreatment by disease activity criteria (Group 2) demonstrated a 14.4 letter gain with a median (mean) of 2.5 (3.5) injections over 12 months. At month 12, the mean change in BCVA was similar across all subgroups. However, there was a positive association observed between the number of injections required and increased total lesion area and CNV lesion area, but not for refraction sphere and axial length. The BCVA outcomes and median (mean) number of injections for the subgroups were: lesion area, mm2 (<1.3/1.3-<3.4/≥3.4: 13.4/14.8/16.8 and 2.0[2.2]/3.0[4.2]/5.0[4.5]); CNV lesion area, mm2 (<0.8/0.8-<2.4/≥2.4: 11.5/16.7/14.2 and 1.0[2.1]/3.0[3.9]/5.0[5.1]); refraction sphere, diopters (<10/10-<20/≥20: 15.5/13.4/14.9 and 3.0[3.7]/2.0[3.2]/2.0[4.4]) and axial length, mm (<28/28-<30/≥30: 16.5/13.1/13.1 and 3.0[3.8]/2.5[2.9]/2.0[3.7]).
The results from this post-hoc subgroup analysis of the RADIANCE study showed that the BCVA outcomes observed in the subgroups were consistent with the overall study population while there was a variation in the number of injections required to achieve these outcomes.