In this double-masked, prospective, randomized, multi-center Phase II age-related macular degeneration (AMD) trial, 157 patients were randomized to five dose groups and treated with vascular endothelial growth factor (VEGF) Trap-Eye in one eye. Two groups initially received monthly doses of 0.5 or 2mg of VEGF Trap-Eye (at weeks 0, four, eight, and 12) and three groups received quarterly doses of 0.5, 2, or 4mg of VEGF Trap-Eye (at baseline and week 12).
Following the initial 12-week fixed-dosing phase of the trial, patients continued to receive therapy at the same dose on a PRN dosing schedule based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria. Patients were monitored for safety, retinal thickness, and visual acuity. These data represent the final one-year analysis from the 52-week study.
Patients receiving four monthly doses of VEGF Trap-Eye, either 2 or 0.5mg, for 12 weeks followed by PRN dosing thereafter, achieved mean improvements in visual acuity versus baseline of nine letters (p<0.0001) and 5.4 letters (p=0.085), respectively, and mean decreases in retinal thickness versus baseline of 143 microns (p<0.0001) and 125 microns (p<0.0001) at week 52, respectively. During the subsequent PRN dosing phase, patients initially dosed on a 2mg monthly schedule received, on average, only 1.6 additional injections and those initially dosed on a 0.5mg monthly schedule received, on average, 2.5 injections. For all dose cohorts combined, there was a 5.3 mean letter gain in visual acuity versus baseline at the week 52 evaluation visit (p<0.0001). The mean decrease in retinal thickness for all dose groups combined at week 52 was 130 microns versus baseline (p<0.0001). During the week 12 to week 52 PRN dosing period, patients from all dose groups combined received, on average, only two additional injections.