TY - JOUR
T1 - Intravitreal aflibercept for diabetic macular edema
AU - Korobelnik, Jean François
AU - Do, Diana V.
AU - Schmidt-Erfurth, Ursula
AU - Boyer, David S.
AU - Holz, Frank G.
AU - Heier, Jeffrey S.
AU - Midena, Edoardo
AU - Kaiser, Peter K.
AU - Terasaki, Hiroko
AU - Marcus, Dennis M.
AU - Nguyen, Quan D.
AU - Jaffe, Glenn J.
AU - Slakter, Jason S.
AU - Simader, Christian
AU - Soo, Yuhwen
AU - Schmelter, Thomas
AU - Yancopoulos, George D.
AU - Stahl, Neil
AU - Vitti, Robert
AU - Berliner, Alyson J.
AU - Zeitz, Oliver
AU - Metzig, Carola
AU - Brown, David M.
N1 - Funding Information:
The VISTA and VIVID studies were funded by Regeneron Pharmaceuticals, Inc. , Tarrytown, NY and Bayer HealthCare , Berlin, Germany. The sponsors participated in the design and conduct of the study, analysis of the data, and preparation of the manuscript.
Publisher Copyright:
© 2014 American Academy of Ophthalmology.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - 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, VISTADME and VIVIDDME.ParticipantsWe 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.
AB - 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, VISTADME and VIVIDDME.ParticipantsWe 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.
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U2 - 10.1016/j.ophtha.2014.05.006
DO - 10.1016/j.ophtha.2014.05.006
M3 - Article
C2 - 25012934
AN - SCOPUS:84908897529
VL - 121
SP - 2247
EP - 2254
JO - Ophthalmology
JF - Ophthalmology
SN - 0161-6420
IS - 11
ER -