RT Journal Article
SR Electronic
T1 Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study
JF British Journal of Ophthalmology
JO Br J Ophthalmol
FD BMJ Publishing Group Ltd.
SP 1436
OP 1443
DO 10.1136/bjophthalmol-2020-318690
VO 106
IS 10
A1 Liu, Kun
A1 Wang, Hanying
A1 He, Wei
A1 Ye, Jian
A1 Song, Yanping
A1 Wang, Yusheng
A1 Liu, Xiaoling
A1 Wu, Zhifeng
A1 Chen, Shaojun
A1 Fan, Ke
A1 Liu, Yuling
A1 Zhang, Feng
A1 Li, Zhiqing
A1 Liu, Lin
A1 Zhang, Junjun
A1 Zhang, Xuedong
A1 Ye, Junjie
A1 Liang, Xiaoling
A1 Li, Xiaoxin
A1 Ke, Xiao
A1 Wu, Quan
A1 Li, Jie
A1 Tao, Shanshan
A1 Wang, Xinguo
A1 Rosenfeld, Philip
A1 Heier, Jeffrey S
A1 Kaiser, Peter
A1 Xu, Xun
YR 2022
UL http://bjo.bmj.com/content/106/10/1436.abstract
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.