Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) and Bayer HealthCare AG (Leverkusen, Germany) have initiated a phase 3 study of VEGF Trap-Eye for treatment of the neovascular form of age-related macular degeneration (AMD).
The study will be a noninferiority comparison of VEGF Trap-Eye and ranibizumab (Lucentis; Genentech, South San Francisco). This trial, VIEW 1, or VEGF Trap: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration, is the company’s first phase 3 global development program in neovascular AMD. Study locations will include the United States and Europe.
The results of early phase studies of VEGF Trap-Eye suggest that it has the potential to be a highly efficacious treatment with less frequent administration compared to existing therapies. If these results are confirmed in phase 3 trials, it would be important for both patients and physicians and could be a significant advance in the treatment of these patients.
The randomized, double-masked phase 3 study is expected to enroll approximately 1,200 patients in more than 200 centers. The study will evaluate the safety and efficacy of the VEGF Trap-Eye at doses of 0.5 and 2.0 mg administered at 4-week dosing intervals, as well as 2.0 mg at an 8-week dosing interval. This will be compared with 0.5 mg of ranibizumab administered every 4 weeks, its labeled dosing schedule.
The primary endpoint of the study is the proportion of patients treated with VEGF Trap-Eye who maintain or improve vision at the end of 1 year compared with ranibizumab patients.
Visual acuity is defined as the total number of letters read correctly on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. Maintenance of vision is defined as losing fewer than three lines (15 letters) on the ETDRS chart. After the first year of treatment, patients will continue to be treated and followed for another year.
In an analysis of interim data from the ongoing phase 2 trial in neovascular AMD, in which patients were treated with VEGF Trap-Eye either monthly or quarterly, combined data for all patients demonstrated a statistically significant reduction in retinal thickness and improvement in visual acuity after 12 weeks compared with baseline. There were no drug-related serious adverse events, and treatment with the VEGF Eye-Trap was generally well tolerated. The most common adverse events were those typically associated with intravitreal injections, according to a company news release.