Abstract
Purpose: :
To evaluate efficacy and safety of different dose and interval regimens of VEGF Trap-Eye (VTE) vs monthly ranibizumab in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) at 12 months in a international setting.
Methods: :
A total of 1240 patients from Europe, Latin America, Asia, and Australia were randomized to VTE 0.5 mg monthly (4 weeks; 0.5q4wk), 2 mg monthly (2q4wk), 2 mg every two months (8 weeks; 2q8wk) following 3 monthly doses, or ranibizumab 0.5 mg monthly (Rq4wk). The primary endpoint was the proportion of patients maintaining vision (loss <15 ETDRS letters) from baseline to week 52. Secondary endpoints included mean change in best corrected visual acuity (BCVA) at Week 52. Central retinal thickness was assessed monthly.
Results: :
There were 72.4% Caucasian and 21.6% Asian patients included. The proportions of patients maintaining vision at week 52 were 94.4%, 96.3%, 95.6%, and 95.6% for Rq4wk, 0.5q4wk, 2q4wk, and 2q8wk, respectively. All VTE arms were non-inferior to ranibizumab. Mean improvements in BCVA for Rq4wk, 0.5q4wk, 2q4wk and 2q8wk were 9.4, 9.7, 7.6, and 8.9 letters; differences between the VTE arms 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. Conjunctival hemorrhage, macular degeneration, retinal hemorrhage, and reduced visual acuity were the most frequent ocular AEs. There were no concerns regarding systemic safety in any arm.
Conclusions: :
Across different ethnicities, VEGF Trap-Eye monthly or every two months was non-inferior to monthly treatment with ranibizumab with a favorable safety profile. Based on the study data, the new management paradigm in wet AMD with treatment every two months using VEGF Trap-Eye can be recommended regardless of the ethnicity.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00637377
Keywords: age-related macular degeneration • vascular endothelial growth factor