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

Research output: Contribution to journalArticle

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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, 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.

Original languageEnglish (US)
Pages (from-to)2247-2254
Number of pages8
JournalOphthalmology
Volume121
Issue number11
DOIs
StatePublished - Nov 1 2014

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Intravitreal Injections
Macular Edema
Lasers
Visual Acuity
Light Coagulation
Optical Coherence Tomography
Diabetic Retinopathy
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Vascular Endothelial Growth Factor A
Blood Vessels
Therapeutics
Blood Platelets
Outcome Assessment (Health Care)
aflibercept
Incidence

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Korobelnik, J. F., Do, D. V., Schmidt-Erfurth, U., Boyer, D. S., Holz, F. G., Heier, J. S., ... 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

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

In: Ophthalmology, Vol. 121, No. 11, 01.11.2014, p. 2247-2254.

Research output: Contribution to journalArticle

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
Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014 Nov 1;121(11):2247-2254. https://doi.org/10.1016/j.ophtha.2014.05.006
Korobelnik, Jean François ; Do, Diana V. ; Schmidt-Erfurth, Ursula ; Boyer, David S. ; Holz, Frank G. ; Heier, Jeffrey S. ; Midena, Edoardo ; Kaiser, Peter K. ; Terasaki, Hiroko ; Marcus, Dennis M. ; Nguyen, Quan D. ; Jaffe, Glenn J. ; Slakter, Jason S. ; Simader, Christian ; Soo, Yuhwen ; Schmelter, Thomas ; Yancopoulos, George D. ; Stahl, Neil ; Vitti, Robert ; Berliner, Alyson J. ; Zeitz, Oliver ; Metzig, Carola ; Brown, David M. / Intravitreal aflibercept for diabetic macular edema. In: Ophthalmology. 2014 ; Vol. 121, No. 11. pp. 2247-2254.
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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, 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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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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