Sailing study and extension study: Superiority of conbercept over laser in DME
The Sailing study was a 12-month, 18-center, randomized, double-masked, double-sham, parallel-controlled, phase 3 trial that was conducted in China and included eyes with center-involved DME that were randomly assigned to undergo either laser photocoagulation followed by as-needed sham intravitreal injections or sham laser photocoagulation followed by as-needed 0.5 mg intravitreal injections of conbercept.
Chinese and US researchers led by first authors Kun Liu, MD, and Hanying Wang, MD, reported that as-needed intravitreal injections of conbercept (KH902, Chengdu Kanghong Biotech Co.) resulted in improved best-corrected visual acuity (BCVA) in patients with diabetic macular edema (DME) and was superior to results achieved with laser photocoagulation.1
Liu and Wang are from the Department of Ophthalmology (aka National Clinical Research Center for Eye Diseases), Shanghai General Hospital, and the School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
The Sailing study was a 12-month, 18-center, randomized, double-masked, double-sham, parallel-controlled, phase 3 trial that was conducted in China and included eyes with center-involved DME that were randomly assigned to undergo either laser photocoagulation followed by as-needed sham intravitreal injections or sham laser photocoagulation followed by as-needed 0.5 mg intravitreal injections of conbercept.
A 12-month open-label extension study followed that included eyes treated with as-needed intravitreal conbercept injections.
The primary endpoint was the change in the BCVA from baseline.
The full-analysis set included 248 eyes; 157 eyes continued into the extension study.
The authors reported that the mean BCVA improved significantly by 8.2 letters from baseline to month 12 in the eyes treated with sham laser photocoagulation followed by as-needed 0.5-mg conbercept intravitreal injections. In contrast, the eyes treated with laser photocoagulation followed by as-needed sham intravitreal injections had an improvement of 0.3 letter.
After being switched to conbercept in the extension study, the patients treated with laser photocoagulation followed by as-needed sham intravitreal injections had a marked improvement in BCVA. No difference was seen in the BCVA between the 2 groups at the end of the extension study.
The investigators concluded that as-needed intravitreal conbercept injections improved the BCVA of patients with DME, and the drug’s efficacy was superior to that of laser photocoagulations. The same efficacy was seen in the eyes treated with laser alone that were switched to conbercept.
Conbercept is not yet approved in the US.
