April 2011
Volume 52, Issue 14
ARVO Annual Meeting Abstract  |   April 2011
Primary Results of an International Phase III Study Using Intravitreal VEGF Trap-Eye Compared to Ranibizumab in Patients with Wet AMD (VIEW 2)
Author Affiliations & Notes
  • Ursula Schmidt-Erfurth
    Ophthalmology Dept, Medical University of Vienna, Vienna, Austria
  • Victor Chong
    The Nuffield Laboratory of Ophthalmology, Oxford, United Kingdom
  • Bernd Kirchhof
    Ophthalmology Dept, University of Cologne, Cologne, Germany
  • Jean-Francois Korobelnik
    Service d'Ophtalmologie, Hopital Pellegrin, Bordeaux, France
  • András Papp
    Szemészeti Klinika, Tömő Budapest, Hungary
  • Majid Anderesi
    Bayer Healthcare, Berlin, Germany
  • Georg Groetzbach
    Bayer Healthcare, Berlin, Germany
  • Bernd Sommerauer
    Bayer Healthcare, Berlin, Germany
  • Rupert Sandbrink
    Bayer Healthcare, Berlin, Germany
  • Yuichiro Ogura
    Department of Ophthalmology and Visual Science, Nagoya, Japan
  • Footnotes
    Commercial Relationships  Ursula Schmidt-Erfurth, Bayer Healthcare (F), Bayer Healthcare, Alcon, Novartis (C); Victor Chong, Bayer Healthcare (F, C); Bernd Kirchhof, Bayer Healthcare (F, C); Jean-Francois Korobelnik, Bayer Healthcare (F, C); András Papp, Bayer Healthcare (F, C); Majid Anderesi, Bayer Healthcare (C, F); Georg Groetzbach, Bayer Healthcare (F, C); Bernd Sommerauer, Bayer Healthcare (F, C); Rupert Sandbrink, Bayer Healthcare (F, C); Yuichiro Ogura, Bayer Healthcare (F, C)
  • Footnotes
    Support  Bayer Healthcare; Regeneron Pharmaceuticals, Inc
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 1650. doi:
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      Ursula Schmidt-Erfurth, Victor Chong, Bernd Kirchhof, Jean-Francois Korobelnik, András Papp, Majid Anderesi, Georg Groetzbach, Bernd Sommerauer, Rupert Sandbrink, Yuichiro Ogura; Primary Results of an International Phase III Study Using Intravitreal VEGF Trap-Eye Compared to Ranibizumab in Patients with Wet AMD (VIEW 2). Invest. Ophthalmol. Vis. Sci. 2011;52(14):1650.

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      © ARVO (1962-2015); The Authors (2016-present)

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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 

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