Abstract
Purpose: :
To evaluate the efficacy and safety of VEGF Trap-Eye (VTE) vs ranibizumab in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Methods: :
In this non-inferiority study conducted in N. America, 1217 patients were randomized to VTE 0.5 mg every month (4 weeks; 0.5q4wk), 2 mg every month (2q4wk), 2 mg every 2 months (8 weeks; 2q8wk) following 3 monthly doses, or ranibizumab 0.5 mg every month (Rq4wk). The proportion of patients avoiding moderate vision loss (patients losing <15 ETDRS letters) from baseline to week 52 was the primary endpoint. Secondary endpoints included the mean change from baseline in best corrected visual acuity by an ETDRS letter score.
Results: :
The proportions of patients maintaining vision at 52 weeks were 94.4%, 95.9%, 95.1%, and 95.1% for Rq4wk, 0.5q4wk, 2q4wk, and 2q8wk, respectively. All VTE groups were non-inferior (non-inferiority margin of 10%) to ranibizumab. Mean improvements from baseline in ETDRS letter score for Rq4wk, 0.5q4wk, 2q4wk and 2q8wk were 8.1, 6.9, 10.9, and 7.9 letters, respectively. 2q4wk was significantly better (P<0.01) than Rq4wk; differences between the other VTE groups and Rq4wk were non-significant. The incidences of ocular treatment emergent adverse events (AEs) were similar across all treatments, with the most frequent AEs associated with the injection procedure, the underlying disease, and/or the aging process. The most frequent ocular AEs were conjunctival hemorrhage, macular degeneration, eye pain, vitreous detachment, and vitreous floaters.
Conclusions: :
Dosing monthly or every two months with VEGF Trap-Eye was non-inferior to monthly ranibizumab. VEGF Trap-Eye was generally well tolerated and had a generally favorable safety profile. Based upon these results, VEGF Trap-Eye may provide convenient management of wet AMD with predictable, every two month dosing.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00509795
Keywords: age-related macular degeneration • vascular endothelial growth factor • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials