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L. Atwater, M. D. Bennett, G. Ng, K. Waite, R. E. Atkinson, C. Otto; The RETORT (Ranibizumab Monthly for Previously Treated Neovascular AMD Demonstrating Angiographic and SD-OCT Activity) Study: 18-54 Month Data. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2057.
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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 Wet AMD.
Treatment data was analyzed in 100 patients with neovascular AMD who had received anti-VEGF induction, maintenance and pro re nata (PRN) therapy in the preceding 42 months. Patients with active angiographic leakage and edema on SD-OCT were Prospectively enrolled into an open-label phase 2 study of intravitreal ranibizumab (0.5 mg) administered monthly for the first 6 months and PRN for the next 6 months. Qualitative SD-OCT, changes in VA (Early Treatment Diabetic Retinopathy Study [ETDRS] letters), central foveal thickness (CFT), fluorescein leakage, and resolution of macular edema are assessed monthly. The last-observation-carried-forward method is used to impute missing data. Safety monitoring includes monthly evaluation of ocular and systemic adverse events.
During the initial 4 to 40 months of anti-VEGF therapy, the 100 patients (121 eyes), experienced a mean (± standard error of the mean [SEM]) VA improvement of 3.48 ± 2.9 letters.When these patients were switched from PRN to monthly treatment, they demonstrated an additional VA improvement (±SEM) of 3.4 ± 0.7 and 5.8 ± 0.7 ETDRS letters at months 6 and 12, respectively. CFT improved by a mean (± SEM) 44.5 ± 7.0 µm at month 12. At study conclusion, compared with baseline: patients previously treated for <12 months (n=26) VA improved 4.9 letters; those treated for 12 to 18 months (n=30) VA improved 6.8 letters; patients previously treated for 18 months (n = 65) VA improved 5.3 additional letters. One patient experienced a transient ischemic attack, and 1 had an RPE tear prior to month 6.
Switching patients with neovascular AMD, from PRN anti-VEGF therapy to Monthly ranibizumab therapy demonstrated additional improvement in both VA and CFT. Regardless of wet AMD duration, all groups appeared to benefit from treating any edema that was identified by SD-OCT. Patients previously treated for >18 months had worse baseline and final VA after therapy compared with patients with newer onset disease(≤18 months). Regardless of disease duration, neovascular AMD patients with edema on SD-OCT may additionally improve VA with monthly ranibizumab therapy.
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