Anna A Plyukhova1, Maria V Budzinskaya1, Kirill M Starostin2, Robert Rejdak3, Claudio Bucolo4, Michele Reibaldi5, Mario D Toro3,6. 1. Federal State Budget Scientific Research Institute "Scientific Research Institute of Eye Diseases", 119021 Moscow, Russia. 2. Medical Affairs, Sanofi-Aventis SA, 125009 Moscow, Russia. 3. Department of General Ophthalmology with Pediatric Service, Medical University of Lublin, 20079 Lublin, Poland. 4. Department of Biomedical and Biotechnological Sciences, School of Medicine, University of Catania, 95123 Catania, Italy. 5. Department of Ophthalmology, University of Turin, 10126 Turin, Italy. 6. Faculty of Medicine, Collegium Medicum Cardinal Stefan Wyszyński University, 01815 Warsaw, Poland.
Abstract
BACKGROUND: Since the efficacy of ranibizumab (RBZ), bevacizumab (BVZ) and aflibercept (AFB) is comparable in neovascular age-related macular degeneration (AMD), we conducted a systematic review and meta-analysis to evaluate the long-term safety profiles of these agents, including ocular safety. METHODS: Systematic review identifying randomized controlled trials (RCTs) comparing RBZ, BVZ and AFB directly published before March 2019. Serious ocular adverse events (SOAE) of special interest were endophthalmitis, pseudo-endophthalmitis, retinal pigment epithelium tear and newly identified macular atrophy. RESULTS: Thirteen RCTs selected for meta-analysis (4952 patients, 8723 people-years follow-up): 10 compared RBZ vs. BVZ and three RBZ vs. AFB. There were no significant differences in almost all adverse events (systemic and ocular) between BVZ, RBZ and AFB in up to two years' follow-up. Macular atrophy was reported heterogeneously and not reported as SOAE in most trials. CONCLUSIONS: Direct comparison of RBZ, BVZ and AFB safety profiles in the RCT network meta-analytical setting have not revealed a consistent benefit of these three commonly used anti-vascular endothelial growth factor (anti-VEGF) agents in AMD. Network model ranking highlighted potential benefits of RBZ in terms of a systemic safety profile; however, this appears a hypothesis rather than a conclusion. Newly identified macular atrophy is underestimated in RCTs-future real-world data should be focused on SOAE.
BACKGROUND: Since the efficacy of ranibizumab (RBZ), bevacizumab (BVZ) and aflibercept (AFB) is comparable in neovascular age-related macular degeneration (AMD), we conducted a systematic review and meta-analysis to evaluate the long-term safety profiles of these agents, including ocular safety. METHODS: Systematic review identifying randomized controlled trials (RCTs) comparing RBZ, BVZ and AFB directly published before March 2019. Serious ocular adverse events (SOAE) of special interest were endophthalmitis, pseudo-endophthalmitis, retinal pigment epithelium tear and newly identified macular atrophy. RESULTS: Thirteen RCTs selected for meta-analysis (4952 patients, 8723 people-years follow-up): 10 compared RBZ vs. BVZ and three RBZ vs. AFB. There were no significant differences in almost all adverse events (systemic and ocular) between BVZ, RBZ and AFB in up to two years' follow-up. Macular atrophy was reported heterogeneously and not reported as SOAE in most trials. CONCLUSIONS: Direct comparison of RBZ, BVZ and AFB safety profiles in the RCT network meta-analytical setting have not revealed a consistent benefit of these three commonly used anti-vascular endothelial growth factor (anti-VEGF) agents in AMD. Network model ranking highlighted potential benefits of RBZ in terms of a systemic safety profile; however, this appears a hypothesis rather than a conclusion. Newly identified macular atrophy is underestimated in RCTs-future real-world data should be focused on SOAE.
Authors: Voraporn Chaikitmongkol; Min Sagong; Timothy Y Y Lai; Gavin S W Tan; Nor Fariza Ngah; Masahito Ohji; Paul Mitchell; Chang-Hao Yang; Paisan Ruamviboonsuk; Ian Wong; Taiji Sakamoto; Anand Rajendran; Youxin Chen; Dennis S C Lam; Chi-Chun Lai; Tien Yin Wong; Chui Ming Gemmy Cheung; Andrew Chang; Adrian Koh Journal: Asia Pac J Ophthalmol (Phila) Date: 2021-11-24
Authors: Nadhini Arumuganathan; Maximilian Robert Justus Wiest; Mario Damiano Toro; Timothy Hamann; Katrin Fasler; Sandrine Anne Zweifel Journal: Sci Rep Date: 2021-09-29 Impact factor: 4.379
Authors: B Sobolewska; B Fehrenbacher; P Münzer; H Kalbacher; S Geue; Konstantinos Stellos; M Schaller; F Ziemssen Journal: J Ophthalmol Date: 2021-06-14 Impact factor: 1.909