May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
Comparison of 2.5 and 5mg/kg Systemic Bevacizumab (Avastin®) in Patients With Neovascular Age-Related Macular Degeneration
Author Affiliations & Notes
  • F. Prager
    Medical University of Vienna, Vienna, Austria
    Ophthalmology,
  • S. Michels
    Medical University of Vienna, Vienna, Austria
    Ophthalmology,
  • W. Geitzenauer
    Medical University of Vienna, Vienna, Austria
    Ophthalmology,
  • L. Vormittag
    Medical University of Vienna, Vienna, Austria
    Oncology,
  • G. Kornek
    Medical University of Vienna, Vienna, Austria
    Oncology,
  • P. J. Rosenfeld
    Ophthalmology, Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida
  • U. Schmidt-Erfurth
    Medical University of Vienna, Vienna, Austria
    Ophthalmology,
  • Footnotes
    Commercial Relationships F. Prager, None; S. Michels, Novartis, R; W. Geitzenauer, None; L. Vormittag, None; G. Kornek, None; P.J. Rosenfeld, Genentech, Eyetech, Alcon Laboratories, F; Genentech, Eyetech Pharmaceuticals, Novartis Ophthalmics, Allergan, Protein Design Labs, Tanox, Genaera, Jerini AG, Quark Inc, Athenagen, C; Genentech, Eyetech, and Novartis Ophthalmics, Zeiss Meditec, R; U. Schmidt-Erfurth, QLT, P; Novartis, R.
  • Footnotes
    Support Bürgermeisterfonds der Stadt Wien, Österreichische Nationalbank, Deutsche Forschungsgemeinschaft
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 1825. doi:https://doi.org/
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      F. Prager, S. Michels, W. Geitzenauer, L. Vormittag, G. Kornek, P. J. Rosenfeld, U. Schmidt-Erfurth; Comparison of 2.5 and 5mg/kg Systemic Bevacizumab (Avastin®) in Patients With Neovascular Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1825. doi: https://doi.org/.

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

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Abstract

Purpose:: To compare 2.5 and 5 mg/kg intravenous bevacizumab in patients with neovascular age-related macular degeneration (AMD).

Methods:: In a prospective cohort study, approved by the local ethics committee and submitted at the european clinical trial database, 14 eyes (8 patients) were treated with 5 mg/kg and 16 eyes (9 patients) with 2.5 mg/kg intravenous bevacizumab. All patients received 3 initial i.v. infusions at 2 week intervals and were monitored at least every 4 weeks by ETDRS visual acuity, optical coherence tomography (OCT), and fluorescein angiography (FA).

Results:: Both groups showed a comparable treatment response at month 6 and 12. Mean visual acuity (VA) increased in the 5 mg/kg group from 56.3 letters (~20/80+1) at baseline to 65.4 letters (~20/50) at month 6 (p< 0.05) and remained relatively stable with 62.7 letters (20/50-2) at months 12 (p< 0.05). Respectively, the 2.5mg/kg group showed an increase in VA from 57 (20/80+2) to 62.6 (20/50-2) (p<0.05) and 66 letters (20/50+1) (p< 0.05). Baseline mean central retinal thickness, as measured by OCT, was 366µm in the 5mg/kg and 333µm in the 2.5 mg/kg group. A month 6 CRT decreased in both groups to 275µm (p<0.05) and 221µm (p<0,05) respectively, and remained decreased at month 12 (245µm (p<0.05) /234µm (p<0.05)). The need for retreatment within 12 months was with a mean of 5 infusions comparable in both groups. No severe drug related adverse events were seen within 12 months follow-up. Few patients showed an increase in blood pressure, which was manageable with oral anti-hypertensive medication. However, no significant increase in mean systolic or diastolic blood pressure was found within 12 months follow-up.

Conclusions:: Systemic bevacizumab therapy using 2.5 and 5mg/kg showed promising and comparable treatment results up to 12 months follow-up. No drug related severe adverse events occurred in follow-up. This treatment modality might be of advantage in patients with bilateral neovascular AMD.

Clinical Trial:: European Clinical Trial Database: 2005-003132-21

Keywords: age-related macular degeneration • retinal neovascularization • imaging methods (CT, FA, ICG, MRI, OCT, RTA, SLO, ultrasound) 
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