VEGF Trap vs. Lucentis: the test begins

VIEW 2, a Phase III trial evaluating the efficacy and safety of VEGF Trap (afilbercept; Regeneron) versus Lucentis (ranibizumab; Novartis) administered by intravitreal injection for the treatment of neovascular age-related macular degeneration (wet AMD), has dosed its first patient.

The VIEW 2 trial, which will enrol approximately 1200 patients in up to 200 centres around Europe, Japan, Asia Pacific and Latin America, is designed to demonstrate non-inferiority of VEGF Trap with Lucentis. It is the second of two Phase III trials, the first of which (VIEW 1) began enrolling patients in the US and Canada in August 2007. Both trials have the same study design and endpoints.

Patients in the trial will be randomized to receive 0.5 mg and 2.0 mg of VEGF Trap at four-week intervals and 2.0 mg at eight-week intervals, with an additional dose of 2.0 mg at week four; ranibizumab patients will receive 0.5 mg doses at four-week intervals. Following one year of treatment, patients will continue to receive treatment at intervals between four and 12 weeks for a further year.

The Phase II trial achieved both primary and secondary endpoints of reduction in retinal thickness and improvement in visual acuity after 12 weeks of treatment with VEGF Trap. The primary endpoint of the Phase III trial is to compare vision maintenance at one year from baseline between patients treated with VEGF Trap in comparison to patients treated with ranibizumab. Initial results from VIEW 2 are expected in 2011.