RADIANCE is a Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) versus verteporfin photodynamic therapy (vPDT) in 277 patients with visual impairment due to myopic choroidal neovascularization (mCNV). Patients were randomized into three treatment groups: 106 patients in group I received treatment with Lucentis on study day 1, as well as one month later, and as needed thereafter; 116 patients in group II received treatment with Lucentis on study day 1 and as needed thereafter; 55 patients in group III received treatment with vPDT on study day 1 and then received treatment with Lucentis or vPDT after month 3.
After three months, the Lucentis groups I and II gained 10.5 and 10.6 letters in visual acuity, respectively, demonstrating a statistically significant improvement over the vPDT group III, which gained 2.2 letters. Patients in group III were allowed to receive Lucentis after month 3 and were followed until month 12. Treatment with Lucentis and vPDT was generally well-tolerated, with low incidences of ocular (0.7 percent) and non-ocular (4.0 percent) serious adverse events reported in groups I and II, and none in group III. No deaths or cases of endophthalmitis, retinal detachment, cerebrovascular events or myocardial infarction occurred.