Jean-François Korobelnik1, Diana V Do2, Ursula Schmidt-Erfurth3, David S Boyer4, Frank G Holz5, Jeffrey S Heier6, Edoardo Midena7, Peter K Kaiser8, Hiroko Terasaki9, Dennis M Marcus10, Quan D Nguyen2, Glenn J Jaffe11, Jason S Slakter12, Christian Simader3, Yuhwen Soo13, Thomas Schmelter14, George D Yancopoulos13, Neil Stahl13, Robert Vitti13, Alyson J Berliner13, Oliver Zeitz15, Carola Metzig14, David M Brown16. 1. Service d'ophtalmologie, Hôpital Pellegrin-CHU de Bordeaux, Bordeaux, France; Université Bordeaux Segalen, Bordeaux, France; INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France. 2. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska. 3. Medical University of Vienna, Vienna, Austria. 4. Retina-Vitreous Associates Medical Group, Beverly Hills, California. 5. Department of Ophthalmology, University of Bonn, Bonn, Germany. 6. Ophthalmic Consultants of Boston and Tufts University School of Medicine, Boston, Massachusetts. 7. Department of Ophthalmology, University of Padova, Padova, Italy. 8. Cole Eye Institute, Cleveland, Ohio. 9. Nagoya University Hospital, Nagoya, Japan. 10. Southeast Retina Center, Augusta, Georgia. 11. Department of Ophthalmology, Duke University, Durham, North Carolina. 12. Vitreous-Retina-Macula Consultants of New York, New York, New York. 13. Regeneron Pharmaceuticals, Inc., Tarrytown, New York. 14. Bayer HealthCare, Berlin, Germany. 15. Bayer HealthCare, Berlin, Germany; University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 16. Retina Consultants of Houston, Houston, Texas. Electronic address: dmbmd@houstonretina.com.
Abstract
PURPOSE: A head-to-head comparison was performed between vascular endothelial growth factor blockade and laser for treatment of diabetic macular edema (DME). DESIGN: Two similarly designed, double-masked, randomized, phase 3 trials, VISTA(DME) and VIVID(DME). PARTICIPANTS: We included 872 patients (eyes) with type 1 or 2 diabetes mellitus who presented with DME with central involvement. METHODS: Eyes received either intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 initial monthly doses (2q8), or macular laser photocoagulation. MAIN OUTCOME MEASURES: The primary efficacy endpoint was the change from baseline in best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52. Secondary efficacy endpoints at week 52 included the proportion of eyes that gained ≥ 15 letters from baseline and the mean change from baseline in central retinal thickness as determined by optical coherence tomography. RESULTS:Mean BCVA gains from baseline to week 52 in the IAI 2q4 and 2q8 groups versus the laser group were 12.5 and 10.7 versus 0.2 letters (P < 0.0001) in VISTA, and 10.5 and 10.7 versus 1.2 letters (P < 0.0001) in VIVID. The corresponding proportions of eyes gaining ≥ 15 letters were 41.6% and 31.1% versus 7.8% (P < 0.0001) in VISTA, and 32.4% and 33.3% versus 9.1% (P < 0.0001) in VIVID. Similarly, mean reductions in central retinal thickness were 185.9 and 183.1 versus 73.3 μm (P < 0.0001) in VISTA, and 195.0 and 192.4 versus 66.2 μm (P < 0.0001) in VIVID. Overall incidences of ocular and nonocular adverse events and serious adverse events, including the Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events and vascular deaths, were similar across treatment groups. CONCLUSIONS: At week 52, IAI demonstrated significant superiority in functional and anatomic endpoints over laser, with similar efficacy in the 2q4 and 2q8 groups despite the extended dosing interval in the 2q8 group. In general, IAI was well-tolerated.
RCT Entities:
PURPOSE: A head-to-head comparison was performed between vascular endothelial growth factor blockade and laser for treatment of diabetic macular edema (DME). DESIGN: Two similarly designed, double-masked, randomized, phase 3 trials, VISTA(DME) and VIVID(DME). PARTICIPANTS: We included 872 patients (eyes) with type 1 or 2 diabetes mellitus who presented with DME with central involvement. METHODS: Eyes received either intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 initial monthly doses (2q8), or macular laser photocoagulation. MAIN OUTCOME MEASURES: The primary efficacy endpoint was the change from baseline in best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52. Secondary efficacy endpoints at week 52 included the proportion of eyes that gained ≥ 15 letters from baseline and the mean change from baseline in central retinal thickness as determined by optical coherence tomography. RESULTS: Mean BCVA gains from baseline to week 52 in the IAI 2q4 and 2q8 groups versus the laser group were 12.5 and 10.7 versus 0.2 letters (P < 0.0001) in VISTA, and 10.5 and 10.7 versus 1.2 letters (P < 0.0001) in VIVID. The corresponding proportions of eyes gaining ≥ 15 letters were 41.6% and 31.1% versus 7.8% (P < 0.0001) in VISTA, and 32.4% and 33.3% versus 9.1% (P < 0.0001) in VIVID. Similarly, mean reductions in central retinal thickness were 185.9 and 183.1 versus 73.3 μm (P < 0.0001) in VISTA, and 195.0 and 192.4 versus 66.2 μm (P < 0.0001) in VIVID. Overall incidences of ocular and nonocular adverse events and serious adverse events, including the Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events and vascular deaths, were similar across treatment groups. CONCLUSIONS: At week 52, IAI demonstrated significant superiority in functional and anatomic endpoints over laser, with similar efficacy in the 2q4 and 2q8 groups despite the extended dosing interval in the 2q8 group. In general, IAI was well-tolerated.
Authors: Jeffrey G Gross; Adam R Glassman; Lee M Jampol; Seidu Inusah; Lloyd Paul Aiello; Andrew N Antoszyk; Carl W Baker; Brian B Berger; Neil M Bressler; David Browning; Michael J Elman; Frederick L Ferris; Scott M Friedman; Dennis M Marcus; Michele Melia; Cynthia R Stockdale; Jennifer K Sun; Roy W Beck Journal: JAMA Date: 2015-11-24 Impact factor: 56.272
Authors: Stephan Radda; Matthias Bolz; Stefan Egger; Vanessa Gasser-Steiner; Martina Kralinger; Stefan Mennel; Christoph Scholda; Ulrike Stolba; Andreas Wedrich; Katharina Krepler Journal: Wien Klin Wochenschr Date: 2016-04 Impact factor: 1.704
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