Sanjeeb Bhandari1, Vuong Nguyen2, Samantha Fraser-Bell2, Hemal Mehta3, Francesco Viola4, Florian Baudin5, Pierre-Henry Gabrielle5, Catherine Creuzot-Garcher5, Mark Gillies2, Daniel Barthelmes6. 1. Discipline of Ophthalmology and Eye Health, Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, Australia. Electronic address: sbha5189@uni.sydney.edu.au. 2. Discipline of Ophthalmology and Eye Health, Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, Australia. 3. Discipline of Ophthalmology and Eye Health, Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, Australia; Department of Ophthalmology, Royal Free London NHS Foundation Trust, London, United Kingdom. 4. Fondazione Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. 5. Department of Ophthalmology, Dijon University Hospital, Dijon, France. 6. Discipline of Ophthalmology and Eye Health, Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, Australia; Department of Ophthalmology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Abstract
PURPOSE: Both ranibizumab and aflibercept improved vision and decreased macular thickness in eyes with diabetic macular edema (DME) in clinical trials. This study compared the 12-month treatment outcomes of each drug in routine clinical practice. DESIGN: Retrospective analysis of data from the prospectively designed observational Fight Retinal Blindness! registry. PARTICIPANTS: Treatment-naive eyes tracked in the registry that initiated treatment with either ranibizumab (0.5 mg) or aflibercept (2 mg) for DME from December 1, 2013, through June 1, 2018. METHODS: Visual acuity (VA) was analyzed at 12 months in all eyes (completers, noncompleters, and eyes that switched treatment). MAIN OUTCOME MEASURES: The primary outcome was the mean change in VA from baseline to 12 months. RESULTS: We identified 383 eyes (ranibizumab, n = 166 eyes; aflibercept, n = 217 eyes) of 291 patients. Eyes receiving aflibercept showed a lower mean VA (mean difference, -3.1 letters) and a thicker maculae (mean difference, +26 μm) at baseline than those receiving ranibizumab, which were not significantly different. Patients receiving ranibizumab were older (mean difference, +2.7 years). The adjusted mean difference in VA change and central subfield thickness (CST) reduction were, respectively, +1 letter (1.4 letters for aflibercept vs. 0.4 letter for ranibizumab; P = 0.4) and -30 μm (-85 vs. -55 μm; P < 0.01) in eyes with initial VA of 20/40 or better and +3 letters (10.6 vs. 7.6 letters; P < 0.01) and -46 μm (-148 vs. -102 μm; P < 0.02) in those with VA of 20/50 or worse. Eyes in the aflibercept group received more median injections over 12 months than the ranibizumab group although this difference was not significant (8 vs. 6 injections; P = 0.13). Treatment switches, albeit low, were more frequent from ranibizumab to aflibercept than vice versa. Significantly more eyes in the aflibercept group were lost to follow-up within 12 months (21% vs. 9% ranibizumab; P < 0.01). CONCLUSIONS: Both drugs were beneficial for DME. Aflibercept-treated eyes, which had borderline worse vision and thicker maculae at baseline, showed larger CST reductions after 12 months of treatment. Larger VA gains were observed with aflibercept treatment when the initial VA was 20/50 or worse.
PURPOSE: Both ranibizumab and aflibercept improved vision and decreased macular thickness in eyes with diabetic macular edema (DME) in clinical trials. This study compared the 12-month treatment outcomes of each drug in routine clinical practice. DESIGN: Retrospective analysis of data from the prospectively designed observational Fight Retinal Blindness! registry. PARTICIPANTS: Treatment-naive eyes tracked in the registry that initiated treatment with either ranibizumab (0.5 mg) or aflibercept (2 mg) for DME from December 1, 2013, through June 1, 2018. METHODS: Visual acuity (VA) was analyzed at 12 months in all eyes (completers, noncompleters, and eyes that switched treatment). MAIN OUTCOME MEASURES: The primary outcome was the mean change in VA from baseline to 12 months. RESULTS: We identified 383 eyes (ranibizumab, n = 166 eyes; aflibercept, n = 217 eyes) of 291 patients. Eyes receiving aflibercept showed a lower mean VA (mean difference, -3.1 letters) and a thicker maculae (mean difference, +26 μm) at baseline than those receiving ranibizumab, which were not significantly different. Patients receiving ranibizumab were older (mean difference, +2.7 years). The adjusted mean difference in VA change and central subfield thickness (CST) reduction were, respectively, +1 letter (1.4 letters for aflibercept vs. 0.4 letter for ranibizumab; P = 0.4) and -30 μm (-85 vs. -55 μm; P < 0.01) in eyes with initial VA of 20/40 or better and +3 letters (10.6 vs. 7.6 letters; P < 0.01) and -46 μm (-148 vs. -102 μm; P < 0.02) in those with VA of 20/50 or worse. Eyes in the aflibercept group received more median injections over 12 months than the ranibizumab group although this difference was not significant (8 vs. 6 injections; P = 0.13). Treatment switches, albeit low, were more frequent from ranibizumab to aflibercept than vice versa. Significantly more eyes in the aflibercept group were lost to follow-up within 12 months (21% vs. 9% ranibizumab; P < 0.01). CONCLUSIONS: Both drugs were beneficial for DME. Aflibercept-treated eyes, which had borderline worse vision and thicker maculae at baseline, showed larger CST reductions after 12 months of treatment. Larger VA gains were observed with aflibercept treatment when the initial VA was 20/50 or worse.
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