Abstract
Background and objectives: Conbercept is a novel anti-vascular endothelial growth factor (VEGF) agent for the treatment of wet age-related macular degeneration (wAMD). However, no head-to-head study has compared the effectiveness of conbercept with that of ranibizumab. In this study, we will compare the effectiveness, cost-effectiveness and safety profiles of ranibizumab and conbercept in the treatment of wAMD. Design: This is a single-center, prospective, cohort study. Methods: Patients (≥ 50 years old) diagnosed with wAMD will be allocated to the conbercept or ranibizumab group according to their preference. Following a treat-and-extend protocol, patients will receive intravitreal injections of 0.5 mg conbercept or 0.5 mg ranibizumab every month in the first three injections. Outcome measures: The primary outcome is quality of life, measured with the Chinese version of the Low Vision Quality of Life Questionnaire, from baseline to 48 weeks post-treatment. Secondary outcomes include best corrected visual acuity, central retinal thickness, cost of treatment, intraocular pressure, and adverse events. The follow-up phase will last 1 year. Propensity score matching will be used to deal with differences in baseline between the two groups. A cost-effectiveness analysis will be performed. Discussion: The results of this study will provide clinicians with a rational basis for choosing the most effective treatment for wAMD patients. Ethics and dissemination: This study has been approved by the Medical Ethics Committee of Guizhou Provincial People’s Hospital (approval number: 2017113). Patient recruitment was initiated in November 2017. Analysis of primary outcome measures will be completed in October 2020, and the study will be finished in October 2021. Dissemination plans include presentations at scientific conferences and publication in scientific journals. Trial registration: This study was registered in the Chinese Clinical Trial Registry with registration number of ChiCRT-OPC-17013023, protocol version: 2.0.
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