PT  - JOURNAL ARTICLE
AU  - Liu, Kun
AU  - Wang, Hanying
AU  - He, Wei
AU  - Ye, Jian
AU  - Song, Yanping
AU  - Wang, Yusheng
AU  - Liu, Xiaoling
AU  - Wu, Zhifeng
AU  - Chen, Shaojun
AU  - Fan, Ke
AU  - Liu, Yuling
AU  - Zhang, Feng
AU  - Li, Zhiqing
AU  - Liu, Lin
AU  - Zhang, Junjun
AU  - Zhang, Xuedong
AU  - Ye, Junjie
AU  - Liang, Xiaoling
AU  - Li, Xiaoxin
AU  - Ke, Xiao
AU  - Wu, Quan
AU  - Li, Jie
AU  - Tao, Shanshan
AU  - Wang, Xinguo
AU  - Rosenfeld, Philip
AU  - Heier, Jeffrey S
AU  - Kaiser, Peter
AU  - Xu, Xun
TI  - Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study
AID  - 10.1136/bjophthalmol-2020-318690
DP  - 2022 Oct 01
TA  - British Journal of Ophthalmology
PG  - 1436--1443
VI  - 106
IP  - 10
4099  - http://bjo.bmj.com/content/106/10/1436.short
4100  - http://bjo.bmj.com/content/106/10/1436.full
SO  - Br J Ophthalmol2022 Oct 01; 106
AB  - Background To demonstrate the efficacy and safety of intravitreal injections of conbercept versus laser photocoagulation in the treatment of diabetic macular oedema (DME).Methods A 12-month multicentre, randomised, double-masked, double-sham, parallel controlled, phase III trial (Sailing Study), followed by a 12-month open-label extension study. Patients with centre-involved DME were randomly assigned to receive either laser photocoagulation followed by pro re nata (PRN) sham intravitreal injections (laser/sham) or sham laser photocoagulation followed by PRN 0.5 mg conbercept intravitreal injections (sham/conbercept). Patients who entered the extension study received PRN conbercept treatment. The primary endpoint was the changes in best-corrected visual acuity (BCVA) from baseline.Results A total of 248 eyes were included in the full analysis set and 157 eyes continued in the extension study. Significant improvement in mean change in BCVA from baseline to month 12 was observed in the sham/conbercept group (8.2±9.5 letters), whereas no improvement was observed in the laser/sham group (0.3±12.0 letters). Patients in the laser/sham group showed a marked improvement in BCVA after the switch to conbercept in the extension study, and there was no difference in BCVA between the two groups at the end of the extension study.Conclusion The use of a conbercept PRN intravitreal injection regimen improved the BCVA of patients with DME, and its efficacy was better than that of laser photocoagulations, and the same efficacy was observed when the eyes treated with laser alone were switched to conbercept.Trial registration number NCT02194634.No data are available. This study is under the supervision of the Ministry of Science and Technology of China, and data sharing cannot be provided temporarily.