Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration

Published:October 18, 2012DOI:https://doi.org/10.1016/j.ophtha.2012.09.006

      Objective

      Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab.

      Design

      Double-masked, multicenter, parallel-group, active-controlled, randomized trials.

      Participants

      Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD.

      Intervention

      Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4).

      Main Outcome Measures

      The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures.

      Results

      All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups.

      Conclusions

      Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring.

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      Linked Article

      • Erratum
        OphthalmologyVol. 120Issue 1
        • In Brief
          With apologies from the authors of “Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration” (Ophthalmology 2012;119:2537–48) one paragraph of the Discussion section was removed and the correctly edited version is bolded in the text below.
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        • PDF
      • Is There Risk of Stroke with Aflibercept?
        OphthalmologyVol. 121Issue 1
        • In Brief
          The VIEW 1 and 2 studies have shown that aflibercept is an effective treatment for neovascular age-related macular degeneration,1 but does it come at a cost of an increased risk of stroke?
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      • Safety in Aflibercept versus Ranibizumab
        OphthalmologyVol. 121Issue 1
        • In Brief
          Aflibercept seems to have equivalent effectiveness to ranibizumab, even though it requires less frequent injections.1 Although the effectiveness of vascular endothelial growth factor (VEGF) inhibitors for age-related macular degeneration (AMD) is unquestionable, there has been some concern for the systemic vascular safety, especially relating to cerebrovascular risk.2-4
        • Full-Text
        • PDF