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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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To compare 2.5 and 5 mg/kg intravenous bevacizumab in patients with neovascular age-related macular degeneration (AMD).
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).
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.
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.
European Clinical Trial Database: 2005-003132-21
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