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K. E. Schmid-Kubista, I. Krebs, B. Gruenberger, J. Schueller, S. Binder; Systemic Bevacizumab Therapy for Exudative Neovascular Age-Related Macular Degeneration (BEAT-AMD-Study). Invest. Ophthalmol. Vis. Sci. 2008;49(13):304.
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The study objective of this prospective, double-blinded, randomized study was to determine the effect of systemic bevacizumab therapy in patients with exudative age-related macular degeneration in both eyes, in comparison to placebo treatment with natrium chloride 0.9%.
Age-related macular degeneration patients with fibrovascular pigment epithelium detachment, subfoveal choroidal neovascularisations extending under the geometric center of the foveal avascular zone, and a central retinal thickness of at least 300µm were included. Exclusion criteria were arterial thromboembolic diseases, cancer, proteinuria, renal impairment, hepatic dysfunction, and vision threatening ophthalmic diseases other than age-related macular degeneration.Patients were randomized to receive 3 intravenous infusions at 2 weeks intervals of either 5mg/kg bevacizumab or 100ml natrium chloride 0.9%. They underwent medical internal reviews, ETDRS and Radner visual acuity assessment, ophthalmologic examinations, ocular imaging with stratus OCT 3, multifocal ERG, fluorescein angiography, and indocyanine angiography at regular intervals. An increase or decrease in visual acuity was defined as a gain or loss of 3 lines (ETDRS). Follow-up time was 6 months.
16 eyes were included and equally randomized 1:1. 10 weeks after beginning of treatment, there was a significant increase (p=0.044) in visual acuity in the bevacizumab group. However, in both groups 7 eyes remained stable and 1 eye had a loss of 3 lines within the follow-up time. There were significant decreases in retinal thickness in the bevacizumab group already after 2 weeks (p=0.007) throughout week 24 (p=0.024). In the natrium chloride group there was a significant decrease in retinal thickness after 12 weeks (p=0.03). There was no significant increase in blood pressure in either group.
We were able to show significant decreases in retinal thickness after treatment with bevacizumab. However, there was only one significant increase in visual acuity in the bevacizumab group after 10 weeks, while there was no gain in visual acuity of more than 3 lines in any group. Due to the high risk factors of systemic bevacizumab treatment, high cost, and minor effect in visual acuity gain we conclude that intravitreal application is a better option.
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