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M. D. Bennett, P. H. Scharper, Jr., R. E. Atkinson, J. S. Bryan; The SWIM (SWitching From Intermittent Anti-VEGF to Monthly Ranibizumab Therapy in Neovascular AMD) Study: 6-Month Data. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2368.
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To determine if switching from intermittent therapy targeting vascular endothelial growth factor (anti-VEGF therapy: pegaptanib, bevacizumab, or ranibizumab) to monthly ranibizumab therapy can improve visual acuity (VA) and anatomic outcomes in patients with neovascular age-related macular degeneration (AMD).
This is an ongoing open-label phase 2 study of intravitreal ranibizumab (0.5 mg) in 100 patients with neovascular AMD who had received ≥3 doses of anti-VEGF therapy pro re nata (PRN) in the preceding 18 months. Ranibizumab is administered monthly for the first 6 months and PRN for the next 6 months based on qualitative optical coherence tomography results. Changes in VA, central foveal thickness (CFT), fluorescein leakage, and resolution of macular edema are assessed monthly. Safety monitoring includes monthly evaluation of ocular and systemic adverse events.
Of 100 patients (121 eyes) enrolled, 57 patients (65 eyes) have interim 6-month data, with a mean (± SEM) overall VA improvement of 2.9 ± 0.8 ETDRS letters from baseline. Eleven patients (11 eyes), 16 patients (19 eyes), and 30 patients (35 eyes) received prior anti-VEGF therapy for <12, 12-18, and >18 months, respectively, and after switching to monthly ranibizumab, achieved mean VA improvements of 4.3 ± 2.2, 2.8 ± 1.1, and 2.2 ± 1.2 letters from baseline, respectively. Overall, there was a decrease in mean CFT of 26.5 ± 12.5 µm from baseline; the 3 patient groups achieved CFT reductions of 22.8 ± 20.1, 0.7 ± 24.8, and 41.7 ± 17.7 µm, respectively. One patient experienced a transient ischemic attack (TIA), and 1 had a retinal tear prior to month 6.
These early results suggest that switching to monthly ranibizumab therapy may be beneficial to patients with neovascular AMD previously treated with intermittent anti-VEGF therapy. Follow-up data should help determine whether the duration of prior PRN treatment significantly affects the incremental gains from monthly therapy.
Clinical Trial: :
NA, as this is a non-comparator trial
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