Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration

Jeffrey S. Heier, David M. Brown, Victor Chong, Jean Francois Korobelnik, Peter K. Kaiser, Quan Dong Nguyen, Bernd Kirchhof, Allen Ho, Yuichiro Ogura, George D. Yancopoulos, Neil Stahl, Robert Vitti, Alyson J. Berliner, Yuhwen Soo, Majid Anderesi, Georg Groetzbach, Bernd Sommerauer, Rupert Sandbrink, Christian Simader, Ursula Schmidt-Erfurth

Research output: Contribution to journalArticle

1064 Citations (Scopus)

Abstract

Objective: Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Design: Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Participants: Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Intervention: Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). Main Outcome Measures: The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. Results: All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Conclusions: Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

Original languageEnglish (US)
Pages (from-to)2537-2548
Number of pages12
JournalOphthalmology
Volume119
Issue number12
DOIs
StatePublished - Dec 1 2012

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Macular Degeneration
Intravitreal Injections
Disclosure
Visual Acuity
aflibercept
Safety
Choroidal Neovascularization
Berlin
Diabetic Retinopathy
Ranibizumab
Germany
Therapeutics
Randomized Controlled Trials
Outcome Assessment (Health Care)
Delivery of Health Care

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Heier, J. S., Brown, D. M., Chong, V., Korobelnik, J. F., Kaiser, P. K., Nguyen, Q. D., ... Schmidt-Erfurth, U. (2012). Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology, 119(12), 2537-2548. https://doi.org/10.1016/j.ophtha.2012.09.006

Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. / Heier, Jeffrey S.; Brown, David M.; Chong, Victor; Korobelnik, Jean Francois; Kaiser, Peter K.; Nguyen, Quan Dong; Kirchhof, Bernd; Ho, Allen; Ogura, Yuichiro; Yancopoulos, George D.; Stahl, Neil; Vitti, Robert; Berliner, Alyson J.; Soo, Yuhwen; Anderesi, Majid; Groetzbach, Georg; Sommerauer, Bernd; Sandbrink, Rupert; Simader, Christian; Schmidt-Erfurth, Ursula.

In: Ophthalmology, Vol. 119, No. 12, 01.12.2012, p. 2537-2548.

Research output: Contribution to journalArticle

Heier, JS, Brown, DM, Chong, V, Korobelnik, JF, Kaiser, PK, Nguyen, QD, Kirchhof, B, Ho, A, Ogura, Y, Yancopoulos, GD, Stahl, N, Vitti, R, Berliner, AJ, Soo, Y, Anderesi, M, Groetzbach, G, Sommerauer, B, Sandbrink, R, Simader, C & Schmidt-Erfurth, U 2012, 'Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration', Ophthalmology, vol. 119, no. 12, pp. 2537-2548. https://doi.org/10.1016/j.ophtha.2012.09.006
Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec 1;119(12):2537-2548. https://doi.org/10.1016/j.ophtha.2012.09.006
Heier, Jeffrey S. ; Brown, David M. ; Chong, Victor ; Korobelnik, Jean Francois ; Kaiser, Peter K. ; Nguyen, Quan Dong ; Kirchhof, Bernd ; Ho, Allen ; Ogura, Yuichiro ; Yancopoulos, George D. ; Stahl, Neil ; Vitti, Robert ; Berliner, Alyson J. ; Soo, Yuhwen ; Anderesi, Majid ; Groetzbach, Georg ; Sommerauer, Bernd ; Sandbrink, Rupert ; Simader, Christian ; Schmidt-Erfurth, Ursula. / Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. In: Ophthalmology. 2012 ; Vol. 119, No. 12. pp. 2537-2548.
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abstract = "Objective: Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Design: Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Participants: Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Intervention: Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). Main Outcome Measures: The primary end point was noninferiority (margin of 10{\%}) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. Results: All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1{\%}, 95.9{\%}, and 95.1{\%}, respectively, for VIEW 1, and 95.6{\%}, 96.3{\%}, and 95.6{\%}, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4{\%} in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Conclusions: Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.",
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T1 - Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration

AU - Heier, Jeffrey S.

AU - Brown, David M.

AU - Chong, Victor

AU - Korobelnik, Jean Francois

AU - Kaiser, Peter K.

AU - Nguyen, Quan Dong

AU - Kirchhof, Bernd

AU - Ho, Allen

AU - Ogura, Yuichiro

AU - Yancopoulos, George D.

AU - Stahl, Neil

AU - Vitti, Robert

AU - Berliner, Alyson J.

AU - Soo, Yuhwen

AU - Anderesi, Majid

AU - Groetzbach, Georg

AU - Sommerauer, Bernd

AU - Sandbrink, Rupert

AU - Simader, Christian

AU - Schmidt-Erfurth, Ursula

PY - 2012/12/1

Y1 - 2012/12/1

N2 - Objective: Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Design: Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Participants: Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Intervention: Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). Main Outcome Measures: The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. Results: All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Conclusions: Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

AB - Objective: Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Design: Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Participants: Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Intervention: Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). Main Outcome Measures: The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. Results: All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Conclusions: Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

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