Visual Outcome and Fluid Changes Between Eyes With Polypoidal Choroidal Vasculopathy Receiving Biosimilar CKD-701 or Reference Ranibizumab Therapy: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial

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 mu m and -0.22 +/- 0.46 mm(3)) were similar to those of ranibizumab group (-96.78 +/- 105.00 mu m and -0.23 +/- 0.54 mm(3)) (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.

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