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Ori Segal, Liran Tiosano, Ayala Pollack, Rita Ehrlich, Itamar Klemperer, Yoreh Barak, nurit mathalone, Michaela Goldstein, Itay Chowers; Aflibercept as a Second Line Therapy for Neovascular Age Related Macular Degeneration Following Initial Bevacizumab Therapy. Invest. Ophthalmol. Vis. Sci. 2016;57(12):522.
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Second line therapy in patients with neovascular age-related macular degeneration (nvAMD) was mostly evaluated in chronic cases following prolong usage of first line treatment. This study aims to evaluate second line aflibecept therapy in nvAMD eyes showing partial or lack of response for initial therapy with bevacizumab.
The Aflibercept as a Second Line Therapy for nvAMD in Israel (ASLI) study is a prospective, multi-center (n=8), open-label, clinical trial. Forty seven nvAMD eyes that had persistent intra retina, sub retinal, or pigment epithelium detachment following 3-9 initial bevacizumab injections. Three monthly intravitreal aflibercept (2mg) injections were administered followed by two bi-monthly injections (weeks 16 and 24), and a final examination at week 28th. According to the investigator discretion, an additional injection was given at week 20. Best corrected visual acuity (BCVA) was evaluated with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and spectral-domain optical coherence tomography (SD-OCT) was performed at each visit. Baseline and final fluorescein angiography were also performed. Change in the central sub-field macular thickness (CST) from baseline to week 28 on OCT was defined as the primary end-point. Secondary end-points included the mean change in BCVA, and structural changes in OCT and FA.
Mean±SD patient's age was 75.2±8.9 years. The mean±SD number of bevacizumab injections prior to enrollment to the study was 5.5±2.1 (range 3-9). CST reduced from mean±SD of 409±127 microns at baseline to 345±89 microns at week 8 (n=43, p<0.05; paired T-Test). 24/47 eyes had at least 5 letters gain, while 9 lost 5 or more letters. Five eyes lost 15 letters or more and 5 gain 15 letters or more. Twenty four patients required the optional treatment at week 20.
Interim results from the ASLI study demonstrate decrease in CST after the first 2 aflibercept injections, and improved BCVA at the end of the study. These preliminary results suggest that intravitreal aflibercept may be effective in eyes with nvAMD that show lack or partial response to initial bevacizumab treatment.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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