• Teer Ba, Lili Zhou, Han Zhang, Xiaoguang Zhang, Shixuan Guo, Huixia Li, Haiyan Tian, Qiqige Caihan, Gang Bai, Jing Zhou, Lao Qi, Xueyan Zhang, and Guisen Zhang.
• School of Public Health, Inner Mongolia Medical University, Hohhot, China.
• Medicine (Baltimore). 2020 Aug 28; 99 (35): e21992.

BackgroundDiabetic macular edema (DME) can cause severe vision impairments for patients with diabetes. Recently, Conbercept has shown efficacy on DME with 3-monthly loading dose injection and pro re nata (PRN, 3+PRN) thereafter in retrospectivetrials. Furthermore, there are some other approaches have been recommended such as 2mg bimonthly (2q8) after 5 initial doses, or Conbercept 0.5mg treat-and-extend, however, some patients still have recurrence of the disease after treatment. Therefore, in order to identify more efficacy and safety approach on Conbercept inpatients with DME, a randomized controlled trial will be performed with 6-monthly loading dose injection and PRN (6+PRN) compared with 3+PRN treatments.MethodsThis study is a multicenter, randomized control trial of Conbecept treating DME in China. Patients with type 2 diabetes suffered from DEM who already planned to receive Conbercept treatment will be recruited. All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment.ResultsThis study will provide a new powerful evidence of the efficacy and safety of Conbecept treating DME.DiscussionThis RTC study will determine whether multiple treatments of Conbercept provide better effectiveness in patients with DME.Trial Registration NumberChiCTR2000032728.

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