Intravitreal aflibercept for diabetic macular edema

Jean François Korobelnik; Diana V. Do; Ursula Schmidt-Erfurth; David S. Boyer; Frank G. Holz; Jeffrey S. Heier; Edoardo Midena; Peter K. Kaiser; Hiroko Terasaki; Dennis M. Marcus; Quan D. Nguyen; Glenn J. Jaffe; Jason S. Slakter; Christian Simader; Yuhwen Soo; Thomas Schmelter; George D. Yancopoulos; Neil Stahl; Robert Vitti; Alyson J. Berliner; Oliver Zeitz; Carola Metzig; David M. Brown

doi:10.1016/j.ophtha.2014.05.006

Intravitreal aflibercept for diabetic macular edema

Jean François Korobelnik, Diana V. Do, Ursula Schmidt-Erfurth, David S. Boyer, Frank G. Holz, Jeffrey S. Heier, Edoardo Midena, Peter K. Kaiser, Hiroko Terasaki, Dennis M. Marcus, Quan D. Nguyen, Glenn J. Jaffe, Jason S. Slakter, Christian Simader, Yuhwen Soo, Thomas Schmelter, George D. Yancopoulos, Neil Stahl, Robert Vitti, Alyson J. BerlinerOliver Zeitz, Carola Metzig, David M. Brown

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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.

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.

Original language	English (US)
Pages (from-to)	2247-2254
Number of pages	8
Journal	Ophthalmology
Volume	121
Issue number	11
DOIs	https://doi.org/10.1016/j.ophtha.2014.05.006
State	Published - Nov 1 2014

ASJC Scopus subject areas

Ophthalmology

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10.1016/j.ophtha.2014.05.006

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Korobelnik, J. F., Do, D. V., Schmidt-Erfurth, U., Boyer, D. S., Holz, F. G., Heier, J. S., Midena, E., Kaiser, P. K., Terasaki, H., Marcus, D. M., Nguyen, Q. D., Jaffe, G. J., Slakter, J. S., Simader, C., Soo, Y., Schmelter, T., Yancopoulos, G. D., Stahl, N., Vitti, R., ... Brown, D. M. (2014). Intravitreal aflibercept for diabetic macular edema. Ophthalmology, 121(11), 2247-2254. https://doi.org/10.1016/j.ophtha.2014.05.006

Korobelnik, JF, Do, DV, Schmidt-Erfurth, U, Boyer, DS, Holz, FG, Heier, JS, Midena, E, Kaiser, PK, Terasaki, H, Marcus, DM, Nguyen, QD, Jaffe, GJ, Slakter, JS, Simader, C, Soo, Y, Schmelter, T, Yancopoulos, GD, Stahl, N, Vitti, R, Berliner, AJ, Zeitz, O, Metzig, C & Brown, DM 2014, 'Intravitreal aflibercept for diabetic macular edema', Ophthalmology, vol. 121, no. 11, pp. 2247-2254. https://doi.org/10.1016/j.ophtha.2014.05.006

@article{f380d90b242e4adca77a835cfde28e5b,

title = "Intravitreal aflibercept for diabetic macular edema",

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, 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.",

author = "Korobelnik, {Jean Fran{\c c}ois} and Do, {Diana V.} and Ursula Schmidt-Erfurth and Boyer, {David S.} and Holz, {Frank G.} and Heier, {Jeffrey S.} and Edoardo Midena and Kaiser, {Peter K.} and Hiroko Terasaki and Marcus, {Dennis M.} and Nguyen, {Quan D.} and Jaffe, {Glenn J.} and Slakter, {Jason S.} and Christian Simader and Yuhwen Soo and Thomas Schmelter and Yancopoulos, {George D.} and Neil Stahl and Robert Vitti and Berliner, {Alyson J.} and Oliver Zeitz and Carola Metzig and Brown, {David M.}",

note = "Publisher Copyright: {\textcopyright} 2014 American Academy of Ophthalmology.",

year = "2014",

month = nov,

day = "1",

doi = "10.1016/j.ophtha.2014.05.006",

language = "English (US)",

volume = "121",

pages = "2247--2254",

journal = "Ophthalmology",

issn = "0161-6420",

publisher = "Elsevier",

number = "11",

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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.

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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Intravitreal aflibercept for diabetic macular edema

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