Karina Berg1, Emina Hadzalic2, Inger Gjertsen3, Vegard Forsaa4, Lars Haakon Berger5, Bettina Kinge6, Hans Henschien7, Kristian Fossen8, Slavica Markovic9, Terje R Pedersen10, Leiv Sandvik11, Ragnheiður Bragadóttir12. 1. Department of Ophthalmology, Oslo University Hospital, Oslo, Norway. Electronic address: karinabb@medisin.uio.no. 2. Department of Ophthalmology, Betanien Hospital, Skien, Norway. 3. Department of Ophthalmology, Vestre Viken Hospital Trust, Drammen, Norway. 4. Department of Ophthalmology, Stavanger University Hospital, Stavanger, Norway. 5. Department of Ophthalmology, Østfold Hospital, Moss, Norway. 6. The Retina Clinic, Aleris, Oslo, Norway. 7. Department of Ophthalmology, Vestfold Hospital, Tønsberg, Norway. 8. Department of Ophthalmology, University Hospital of Northern Norway, Tromsø, Norway. 9. Department of Ophthalmology, Innlandet Hospital, Elverum, Norway. 10. Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway. 11. Department of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway. 12. Department of Ophthalmology, Oslo University Hospital, Oslo, Norway.
Abstract
PURPOSE: To compare the efficacy and safety of bevacizumab (Avastin; F. Hoffmann-La Roche Ltd, Basel, Switzerland) versus ranibizumab (Lucentis; Novartis Pharma AG, Basel, Switzerland) for neovascular age-related macular degeneration (nAMD) after 2 years when using a treat-and-extend protocol. DESIGN: Multicenter, randomized, noninferiority trial with a noninferiority limit of 5 letters. PARTICIPANTS: Patients 50 years of age or older with previously untreated nAMD in 1 eye and best-corrected visual acuity 20/25 to 20/320. METHODS: Patients were assigned randomly to receive intravitreal injections with either ranibizumab 0.5 mg or bevacizumab 1.25 mg. Injections were given every 4 weeks until inactive disease was achieved. The treatment interval then was extended by 2 weeks at a time up to a maximum of 12 weeks. In the event of a recurrence, the treatment interval was shortened by 2 weeks at a time. MAIN OUTCOME MEASURE: Mean change in visual acuity at 2 years. RESULTS: Of a total of 441 randomized patients, 339 patients (79%) completed the 2-year visit. According to per-protocol analysis at 2 years, bevacizumab was equivalent to ranibizumab, with 7.4 and 6.6 letters gained, respectively (95% confidence interval [CI] of mean difference, -4.1 to 2.5; P = 0.634). Intention-to-treat analysis was concordant, with a gain of 7.8 letters for bevacizumab and 7.5 letters for ranibizumab (95% CI of mean difference, -3.2 to 2.7; P = 0.873). The 2-year results did not show any significant difference in mean central retinal thickness, with a decrease of -113 μm for bevacizumab and -122 μm for ranibizumab (95% CI of mean difference, -32 to 15; P = 0.476). There was a statistically significant difference between the drugs regarding the number of treatments given, with 18.2 injections for bevacizumab and 16.0 injections for ranibizumab (95% CI of mean difference, -3.4 to -1.0; P ≤ 0.001). The number of serious adverse events was similar between the groups over the course of the study. CONCLUSIONS: At 2 years, bevacizumab and ranibizumab had an equivalent effect on visual acuity and reduction of central retinal thickness when administered according to a treat-and-extend protocol for nAMD. There was no significant difference in the number of serious adverse events between the treatment groups.
RCT Entities:
PURPOSE: To compare the efficacy and safety of bevacizumab (Avastin; F. Hoffmann-La Roche Ltd, Basel, Switzerland) versus ranibizumab (Lucentis; Novartis Pharma AG, Basel, Switzerland) for neovascular age-related macular degeneration (nAMD) after 2 years when using a treat-and-extend protocol. DESIGN: Multicenter, randomized, noninferiority trial with a noninferiority limit of 5 letters. PARTICIPANTS: Patients 50 years of age or older with previously untreated nAMD in 1 eye and best-corrected visual acuity 20/25 to 20/320. METHODS:Patients were assigned randomly to receive intravitreal injections with either ranibizumab 0.5 mg or bevacizumab 1.25 mg. Injections were given every 4 weeks until inactive disease was achieved. The treatment interval then was extended by 2 weeks at a time up to a maximum of 12 weeks. In the event of a recurrence, the treatment interval was shortened by 2 weeks at a time. MAIN OUTCOME MEASURE: Mean change in visual acuity at 2 years. RESULTS: Of a total of 441 randomized patients, 339 patients (79%) completed the 2-year visit. According to per-protocol analysis at 2 years, bevacizumab was equivalent to ranibizumab, with 7.4 and 6.6 letters gained, respectively (95% confidence interval [CI] of mean difference, -4.1 to 2.5; P = 0.634). Intention-to-treat analysis was concordant, with a gain of 7.8 letters for bevacizumab and 7.5 letters for ranibizumab (95% CI of mean difference, -3.2 to 2.7; P = 0.873). The 2-year results did not show any significant difference in mean central retinal thickness, with a decrease of -113 μm for bevacizumab and -122 μm for ranibizumab (95% CI of mean difference, -32 to 15; P = 0.476). There was a statistically significant difference between the drugs regarding the number of treatments given, with 18.2 injections for bevacizumab and 16.0 injections for ranibizumab (95% CI of mean difference, -3.4 to -1.0; P ≤ 0.001). The number of serious adverse events was similar between the groups over the course of the study. CONCLUSIONS: At 2 years, bevacizumab and ranibizumab had an equivalent effect on visual acuity and reduction of central retinal thickness when administered according to a treat-and-extend protocol for nAMD. There was no significant difference in the number of serious adverse events between the treatment groups.
Authors: Maureen G Maguire; Daniel F Martin; Gui-Shuang Ying; Glenn J Jaffe; Ebenezer Daniel; Juan E Grunwald; Cynthia A Toth; Frederick L Ferris; Stuart L Fine Journal: Ophthalmology Date: 2016-05-02 Impact factor: 12.079
Authors: Sharon D Solomon; Kristina Lindsley; Satyanarayana S Vedula; Magdalena G Krzystolik; Barbara S Hawkins Journal: Cochrane Database Syst Rev Date: 2019-03-04