Phase 3 Sailing Study: Intravitreal conbercept administered as needed improves vision in patients with DME
The drug’s efficacy was reported to be superior to that achieved with laser photocoagulation.
Kun Liu, MD, Department of Ophthalmology, Shanghai General Hospital Shanghai, China, and associates from multiple centers in China and the US, reported that intravitreal conbercept (KH902, Chengdu Kanghong Biotech Co.) injections administered as needed improved the best-corrected visual acuity (BCVA) of patients with diabetic macular edema (DME).1
The drug’s efficacy was reported to be superior to that achieved with laser photocoagulation.
Conbercept, as described by the investigators, is a recombinant fusion protein with key domains 2, 3, and 4 from vascular endothelial growth factor (VEGF) receptors 1 and 2. The drug has high affinity for all VEGF isoforms and placental growth factor, they explained.
Phase 3 trial of conbercept for the treatment of DME
The investigators conducted a 12-month multicenter, randomized, double-masked, double-sham, parallel controlled, phase III trial that was followed by a 12-month open-label extension study.
The patients with center-involved DME were randomized to either laser photocoagulation treatment followed by as-needed sham intravitreal injections (laser/sham) or sham laser photocoagulation followed by as-needed 0.5-mg conbercept intravitreal injections (sham/conbercept), the authors described. Patients who continued into the extension study were treated with conbercept as needed.
The primary endpoint was the change in the best-corrected visual acuity (BCVA) compared with baseline.
The data from 248 eyes were analyzed and 157 eyes were included in the extension study.
Liu and colleagues reported a significant improvement (mean, 8.2±9.5 letters) in the change in the BCVA from baseline to month 12 in the sham/conbercept group. In contrast, no meaningful improvement (0.3±12.0 letters) in the BCVA was seen in the laser/sham group.
The patients in the laser/sham group had a marked improvement in the BCVA when they were switched to conbercept in the extension study. No difference was seen in the BCVA between the two groups at the end of the extension study.
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.
The authors concluded that intravitreal conbercept injections administered as needed results in improvements in the BCVA in patients with DME. In addition, the drug’s efficacy was superior to that of laser photocoagulation, and the same efficacy was seen when the eyes treated with laser alone were switched to conbercept.
