PURPOSE: To report early outcomes of a prospective, double-masked, controlled trial comparing bevacizumab (Avastin; Genentech Inc, South San Francisco, California, USA) to ranibizumab (Lucentis; Genentech Inc) for the treatment of age-related macular degeneration. DESIGN: Prospective, double-masked, randomized clinical trial. METHODS: This is a single-center, randomized clinical trial at the Boston Veterans Affairs Healthcare System. Patients who met inclusion criteria were randomized 2:1 to bevacizumab or ranibizumab. Each patient contributed 1 eye to the study. All subjects and investigators (except for the pharmacist responsible for study assignments) were masked to treatment arms. Visual acuity (VA) was checked on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Patients were given either bevacizumab or ranibizumab every month for the first 3 months, followed by optical coherence tomography-guided, variable-dosing schedule. Main outcomes measured were VA and foveal thickness. RESULTS:Twenty patients completed the 6-month follow up. Thirteen patients received bevacizumab and 7 patients received ranibizumab. No subjects in either group lost more than 15 letters on ETDRS chart. The average preoperative VA was 31.6 letters in the bevacizumab group and 30.4 letters in the ranibizumab group. At 6 months follow-up, mean vision was 46.4 letters in the bevacizumab group and 37.4 letters in the ranibizumab group. Two-tailed ttest failed to show statistical significance between the two groups. Patients in the bevacizumab group underwent an average of 5 injections, while patients in the ranibizumab group underwent a mean of 4 injections. CONCLUSION: Early results of a head-to-head, randomized, double-masked, prospective, single-center controlled trial between bevacizumab and ranibizumab show no difference in efficacy between the two treatments for choroidal neovascularizaton in the treatment of age-related macular degeneration. As this study conveys results of a small number of patients, further studies with larger sample sizes are needed in order to establish statistical significance.
RCT Entities:
PURPOSE: To report early outcomes of a prospective, double-masked, controlled trial comparing bevacizumab (Avastin; Genentech Inc, South San Francisco, California, USA) to ranibizumab (Lucentis; Genentech Inc) for the treatment of age-related macular degeneration. DESIGN: Prospective, double-masked, randomized clinical trial. METHODS: This is a single-center, randomized clinical trial at the Boston Veterans Affairs Healthcare System. Patients who met inclusion criteria were randomized 2:1 to bevacizumab or ranibizumab. Each patient contributed 1 eye to the study. All subjects and investigators (except for the pharmacist responsible for study assignments) were masked to treatment arms. Visual acuity (VA) was checked on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Patients were given either bevacizumab or ranibizumab every month for the first 3 months, followed by optical coherence tomography-guided, variable-dosing schedule. Main outcomes measured were VA and foveal thickness. RESULTS: Twenty patients completed the 6-month follow up. Thirteen patients received bevacizumab and 7 patients received ranibizumab. No subjects in either group lost more than 15 letters on ETDRS chart. The average preoperative VA was 31.6 letters in the bevacizumab group and 30.4 letters in the ranibizumab group. At 6 months follow-up, mean vision was 46.4 letters in the bevacizumab group and 37.4 letters in the ranibizumab group. Two-tailed ttest failed to show statistical significance between the two groups. Patients in the bevacizumab group underwent an average of 5 injections, while patients in the ranibizumab group underwent a mean of 4 injections. CONCLUSION: Early results of a head-to-head, randomized, double-masked, prospective, single-center controlled trial between bevacizumab and ranibizumab show no difference in efficacy between the two treatments for choroidal neovascularizaton in the treatment of age-related macular degeneration. As this study conveys results of a small number of patients, further studies with larger sample sizes are needed in order to establish statistical significance.
Authors: Lu Liu; David A Ammar; Lindsey A Ross; Naresh Mandava; Malik Y Kahook; John F Carpenter Journal: Invest Ophthalmol Vis Sci Date: 2011-02-22 Impact factor: 4.799
Authors: Jonathan H Lim; Sanjeewa S Wickremasinghe; Jing Xie; Devinder S Chauhan; Paul N Baird; Luba D Robman; Gregory Hageman; Robyn H Guymer Journal: Am J Ophthalmol Date: 2012-01-14 Impact factor: 5.258
Authors: Francesco Parmeggiani; Donato Gemmati; Ciro Costagliola; Francesco Semeraro; Paolo Perri; Sergio D'Angelo; Mario R Romano; Katia De Nadai; Adolfo Sebastiani; Carlo Incorvaia Journal: Mol Diagn Ther Date: 2011-08-01 Impact factor: 4.074
Authors: Sharon D Solomon; Kristina Lindsley; Satyanarayana S Vedula; Magdalena G Krzystolik; Barbara S Hawkins Journal: Cochrane Database Syst Rev Date: 2014-08-29
Authors: Angela M Carneiro; Luis S Mendonça; Manuel S Falcão; Sofia L Fonseca; Elisete M Brandão; Fernando M Falcão-Reis Journal: Clin Ophthalmol Date: 2012-07-19