First Author: T.Lai HONG KONG
Co Author(s): T.Y. Wong P. Lanzetta N. Heinrichs S. Pilz K. Ohno-Matsui 0 0 0 0 0 0 0 0 0
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Pathologic myopia (PM) is a leading cause of visual impairment (VI) and blindness worldwide. The prevalence of VI due to PM is reported to be higher in East-Asians than Caucasians (12-27% and 6-8% respectively). In the RADIANCE study, that included patients with VI due to myopic choroidal neovascularization (CNV), ranibizumab improved mean best-corrected visual acuity (BCVA) by 14.4 letters with a median of two injections at Month 12 (treatment group guided by disease activity). This post-hoc subgroup analysis explored the treatment response comparing East-Asians and Caucasians with respect to BCVA outcome and treatment exposure.
A post-hoc subgroup analysis 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 visual acuity stabilization), Group 2 (ranibizumab treatment guided by disease activity), or Group 3 (verteporfin photodynamic therapy [vPDT] and as of Month 3, ranibizumab and/or vPDT at investigators' discretion). This subgroup analysis included Group 2 patients only, which was the basis for the approved ranibizumab label for treatment of VI due to myopic CNV. The analysis was exploratory and subgroup data were analyzed using descriptive statistics. The outcome measures were mean change in BCVA from baseline to Month 12 and number of injections administered over 12 months.
The baseline demographic and ocular characteristics (study eye) were generally similar between the two subgroups. For East-Asians and Caucasians: mean age (54.2 and 58.0 years), gender (female: 80.0 and 75.7%), baseline BCVA (54.2 and 55.9 early treatment diabetic retinopathy study [ETDRS] letters), axial length (28.4 and 28.9 mm), refraction sphere (10.7 and 11.8 diopters), and lesion size (2.8 and 2.5 mm2). At Month 12, ranibizumab treatment resulted in a mean BCVA improvement of 16.1 letters from baseline with a median of 2.0 (mean: 2.9) injections in East-Asian patients and 14.1 letters with a median of 3.0 (mean: 3.8) injections in Caucasian patients.
At Month 12, East-Asian patients with myopic CNV showed numerically higher BCVA gain than Caucasians with one less ranibizumab injection. Further studies are required to explore underlying reasons and potential predictors of BCVA outcome and number of injections in these ethnic groups.