2-Month Outcomes of Conbercept in Macular Edema Secondary to Central Retinal Vein Occlusion from a randomized, multicenter, double-blind, sham-controlled phase III study: CRAVE Study

Abstract Purpose To evaluate the efficacy and safety of intravitreal injection of conbercept for the treatment of macular edema secondary to central retinal vein occlusion (CRVO-ME). Methods Patients with CRVO were randomly divided into the treatment (conbercept injection) and control groups (sham injection) at a ratio of 2:1. The primary endpoint was the mean changes in best-corrected visual acuity (BCVA) from baseline to month 6. Results From baseline to month 6, the mean change in BCVA letters were 13.6 ± 12.1 (P < 0.0001) and − 2.2 ± 16.5 (P = 0.2188) in the treatment and control groups. From baseline to month 12, the mean change in BCVA letters were 14.4 ± 13.8 (P < 0.0001) and 3.0 ± 17.6 (P < 0.0001). The mean reduction of CRT from baseline to month 6 were 138.4 ± 99.4 µm (P < 0.0001) and 35.1 ± 98.8 µm (P = 0.0018). From baseline to month 12, the mean reduction values of CRT were 145.1 ± 105.1 µm (P < 0.0001) and 81.7 ± 107.9 µm (P < 0.0001). No new safety events were identified. Conclusions Intravitreal injection of conbercept has definite efficacy and expected controllable safety in patients with CRVO-ME, providing a more flexible strategy for conbercept in the clinical treatment of CRVO-ME. Trial Registration: ClinicalTrials.gov Identifier: NCT03223714, Date: July 21, 2017.