A comparative study between ranibizumab and its first biosimilar razumab in terms of efficacy and safety in DME, RVO and wet AMD associated with CNVM

Abstract

To compare safety and efficacy of intravitreal therapy between anti vascular endothelial growth factor (Anti-VEGF) Ranibizumab and biosimilar Razumab in diabetic macular oedema (DME), wet age related macular degeneration (AMD) with choroidal neovascular membrane (CNVM) and retinal vein occlusion (RVO). Prospective comparative study involved 60 eyes of 56 adults, randomized into 2 groups from September 2016 to November 2017. Group 1 (n=30) received Ranibizumab (0.5mg in 0.05ml) and group 2(n=30) Razumab (0.5mg in 0.05ml). Initial loading dose of one injection given to all subjects and a pro re nata schedule followed thereafter. Patients received maximum of 3 injections and were followed up to 12 weeks. Best corrected visual acuity (BCVA) and central foveal thickness (CFT) were considered for the primary outcome and adverse drug reactions (ADR) was considered in the secondary outcome. A p value of less than 0.05 was considered statistically significant. The 12-week mean BCVA in group 1 was 0.39 (+-0.24); and in group 2 was 0.53 (+-0.37), which had improved significantly from baseline (group 1 p= 0.007, group 2 p <0.001). Inter group comparison was statistically insignificant (p=0.249). The 12 weeks mean CFT in group 1 was 308 (+-107.26) ; and group 2 was 307.60 (+- 87.15), which had improved significantly from baseline in both groups (p <0.001). Inter group difference was statistically insignificant (p=0.544). One patient in group 2 experienced an ADR (p=0.305). In this study both Ranibizumab and Razumab were safe and efficacious.