JAN 21, 2019
In this phase 3 trial, researchers evaluated the efficacy and safety of intravitreal conbercept, a new anti–VEGF drug for wet AMD.
This was a multicenter, double-masked, sham-controlled, phase 3 randomized trial that included 114 patients who completed 12 months of follow up. Patients in the treatment arm received monthly intravitreal injections of conbercept (0.5 mg) for the first 3 months, followed by 1 injection every 3 months until month 12. The sham group started a similar treatment protocol with sham injections, followed by the same conbercept regimen as the treatment group beginning at month 3.
At 3 months, there was a mean change of 9 letters in the conbercept group versus a 2-letter change in the sham group. By 12 months, patients in the conbercept group gained 10 letters compared with 8.8 letters in the sham group.
As this study was conducted in China, the demographics and genetics of the patients there may differ from those in other populations. Specifically, the prevalence of polypoidal choroidal vasculopathy may be more common in a Chinese population than in other groups.
This trial shows meaningful visual acuity improvement comparable to other currently available anti-VEGF treatments. The visual acuity outcomes were maintained at 1 year with every 12-week dosing after the initial loading phase. Additional work will need to be performed to see if these results are able to be maintained for a longer period of time, whether certain patients would do better with different dosing intervals, and whether patients from different races will respond similarly. A phase 3 trial is currently underway in the United States.