Visual outcome and fluid changes in eyes with polypoidal choroidal vasculopathy (PCV) between biosimilar CKD-701 and reference ranibizumab

초록

Purpose : To compare the visual outcome and fluid features of the proposed biosimilar CKD-701 versus the reference ranibizumab in eyes with PCV. Methods : A total of 73 patients with PCV was randomly assigned to either CKD-701 (36 eyes) or ranibizumab (37 eyes). After three-monthly injections, the eyes were treated with pro re nata regimen during 1 year. Mean changes in best-corrected visual acuity (BCVA), central retinal thickness (CRT), pigment epithelial detachment (PED) volume and fluid features were compared. Results : After three monthly loading injections, the mean change in BCVA (letters) was 6.32 ± 7.17 for CKD-701 and 6.43 ± 8.13 for ranibizumab (P = 0.447). The changes in CRT and PED volume of the CKD-701 group (-107.25 ± 102.66 μm and -0.22 ± 0.46 mm3) were similar to those of ranibizumab group (-96.78 ± 105.00 μm and -0.23 ± 0.54 mm3) (P = 0.668 and P = 0.943). Proportions of eyes with subretinal, intraretinal and sub-retinal pigment epithelium fluids at 3 months were 30.6%, 13.9% and 42.9% in CKD-701 group and 51.4%, 16.2% and 40.0% in ranibizumab group (P = 0.071, P = 1.000 and P = 0.808). The visual and anatomical changes were similar between two groups at 12 months (all, P > 0.05). Conclusions : Biosimilar CKD-701 monotherapy resulted comparable visual and anatomical changes to reference ranibizumab in PCV eyes.