Intravitreal aflibercept injection for neovascular age-related macular degeneration: Ninety-six-week results of the VIEW studies

Ursula Schmidt-Erfurth, Peter K. Kaiser, Jean François Korobelnik, David M. Brown, Victor Chong, Quan Dong Nguyen, Allen C. Ho, Yuichiro Ogura, Christian Simader, Glenn J. Jaffe, Jason S. Slakter, George D. Yancopoulos, Neil Stahl, Robert Vitti, Alyson J. Berliner, Yuhwen Soo, Majid Anderesi, Olaf Sowade, Oliver Zeitz, Christiane NorenbergRupert Sandbrink, Jeffrey S. Heier

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Abstract

Purpose To determine efficacy and safety of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) during a second year of variable dosing after a first-year fixed-dosing period. Design Two randomized, double-masked, active-controlled, phase 3 trials. Participants Two thousand four hundred fifty-seven patients with neovascular AMD. Methods From baseline to week 52, patients received 0.5 mg intravitreal ranibizumab every 4 weeks (Rq4), 2 mg aflibercept every 4 weeks (2q4), 0.5 mg aflibercept every 4 weeks (0.5q4), or 2 mg aflibercept every 8 weeks (2q8) after 3 monthly injections. During weeks 52 through 96, patients received their original dosing assignment using an as-needed regimen with defined retreatment criteria and mandatory dosing at least every 12 weeks. Main Outcome Measures Proportion of eyes at week 96 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA. Results Proportions of eyes maintaining BCVA across treatments were 94.4% to 96.1% at week 52 and 91.5% to 92.4% at week 96. Mean BCVA gains were 8.3 to 9.3 letters at week 52 and 6.6 to 7.9 letters at week 96. Proportions of eyes without retinal fluid decreased from week 52 (60.3% to 72.4%) to week 96 (44.6% to 54.4%), and more 2q4 eyes were without fluid at weeks 52 and 96 than Rq4 eyes (difference of 10.4% [95% confidence interval {CI}, 4.9-15.9] and 9.0% [95% CI, 3.0-15.1]). Patients received on average 16.5, 16.0, 16.2, and 11.2 injections over 96 weeks and 4.7, 4.1, 4.6, and 4.2 injections during weeks 52 through 96 in the Rq4, 2q4, 0.5q4, and 2q8 groups, respectively. The number of injections during weeks 52 through 96 was lower in the 2q4 and 2q8 groups versus the Rq4 group (differences of -0.64 [95% CI, -0.89 to -0.40] and -0.55 [95% CI, -0.79 to -0.30]; P < 0.0001, post hoc analysis). Incidences of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were similar across groups (2.4% to 3.8%) from baseline to week 96. Conclusions All aflibercept and ranibizumab groups were equally effective in improving BCVA and preventing BCVA loss at 96 weeks. The 2q8 aflibercept group was similar to ranibizumab in visual acuity outcomes during 96 weeks, but with an average of 5 fewer injections. Small losses at 96 weeks in the visual and anatomic gains seen at 52 weeks in all arms were in the range of losses commonly observed with variable dosing.

Original languageEnglish (US)
Pages (from-to)193-201
Number of pages9
JournalOphthalmology
Volume121
Issue number1
DOIs
StatePublished - Jan 1 2014

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Intravitreal Injections
Macular Degeneration
Injections
Confidence Intervals
Visual Acuity
Retreatment
aflibercept
Arm
Outcome Assessment (Health Care)
Safety
Incidence
Ranibizumab

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Schmidt-Erfurth, U., Kaiser, P. K., Korobelnik, J. F., Brown, D. M., Chong, V., Nguyen, Q. D., ... Heier, J. S. (2014). Intravitreal aflibercept injection for neovascular age-related macular degeneration: Ninety-six-week results of the VIEW studies. Ophthalmology, 121(1), 193-201. https://doi.org/10.1016/j.ophtha.2013.08.011

Intravitreal aflibercept injection for neovascular age-related macular degeneration : Ninety-six-week results of the VIEW studies. / Schmidt-Erfurth, Ursula; Kaiser, Peter K.; Korobelnik, Jean François; Brown, David M.; Chong, Victor; Nguyen, Quan Dong; Ho, Allen C.; Ogura, Yuichiro; Simader, Christian; Jaffe, Glenn J.; Slakter, Jason S.; Yancopoulos, George D.; Stahl, Neil; Vitti, Robert; Berliner, Alyson J.; Soo, Yuhwen; Anderesi, Majid; Sowade, Olaf; Zeitz, Oliver; Norenberg, Christiane; Sandbrink, Rupert; Heier, Jeffrey S.

In: Ophthalmology, Vol. 121, No. 1, 01.01.2014, p. 193-201.

Research output: Contribution to journalArticle

Schmidt-Erfurth, U, Kaiser, PK, Korobelnik, JF, Brown, DM, Chong, V, Nguyen, QD, Ho, AC, Ogura, Y, Simader, C, Jaffe, GJ, Slakter, JS, Yancopoulos, GD, Stahl, N, Vitti, R, Berliner, AJ, Soo, Y, Anderesi, M, Sowade, O, Zeitz, O, Norenberg, C, Sandbrink, R & Heier, JS 2014, 'Intravitreal aflibercept injection for neovascular age-related macular degeneration: Ninety-six-week results of the VIEW studies', Ophthalmology, vol. 121, no. 1, pp. 193-201. https://doi.org/10.1016/j.ophtha.2013.08.011
Schmidt-Erfurth, Ursula ; Kaiser, Peter K. ; Korobelnik, Jean François ; Brown, David M. ; Chong, Victor ; Nguyen, Quan Dong ; Ho, Allen C. ; Ogura, Yuichiro ; Simader, Christian ; Jaffe, Glenn J. ; Slakter, Jason S. ; Yancopoulos, George D. ; Stahl, Neil ; Vitti, Robert ; Berliner, Alyson J. ; Soo, Yuhwen ; Anderesi, Majid ; Sowade, Olaf ; Zeitz, Oliver ; Norenberg, Christiane ; Sandbrink, Rupert ; Heier, Jeffrey S. / Intravitreal aflibercept injection for neovascular age-related macular degeneration : Ninety-six-week results of the VIEW studies. In: Ophthalmology. 2014 ; Vol. 121, No. 1. pp. 193-201.
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title = "Intravitreal aflibercept injection for neovascular age-related macular degeneration: Ninety-six-week results of the VIEW studies",
abstract = "Purpose To determine efficacy and safety of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) during a second year of variable dosing after a first-year fixed-dosing period. Design Two randomized, double-masked, active-controlled, phase 3 trials. Participants Two thousand four hundred fifty-seven patients with neovascular AMD. Methods From baseline to week 52, patients received 0.5 mg intravitreal ranibizumab every 4 weeks (Rq4), 2 mg aflibercept every 4 weeks (2q4), 0.5 mg aflibercept every 4 weeks (0.5q4), or 2 mg aflibercept every 8 weeks (2q8) after 3 monthly injections. During weeks 52 through 96, patients received their original dosing assignment using an as-needed regimen with defined retreatment criteria and mandatory dosing at least every 12 weeks. Main Outcome Measures Proportion of eyes at week 96 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA. Results Proportions of eyes maintaining BCVA across treatments were 94.4{\%} to 96.1{\%} at week 52 and 91.5{\%} to 92.4{\%} at week 96. Mean BCVA gains were 8.3 to 9.3 letters at week 52 and 6.6 to 7.9 letters at week 96. Proportions of eyes without retinal fluid decreased from week 52 (60.3{\%} to 72.4{\%}) to week 96 (44.6{\%} to 54.4{\%}), and more 2q4 eyes were without fluid at weeks 52 and 96 than Rq4 eyes (difference of 10.4{\%} [95{\%} confidence interval {CI}, 4.9-15.9] and 9.0{\%} [95{\%} CI, 3.0-15.1]). Patients received on average 16.5, 16.0, 16.2, and 11.2 injections over 96 weeks and 4.7, 4.1, 4.6, and 4.2 injections during weeks 52 through 96 in the Rq4, 2q4, 0.5q4, and 2q8 groups, respectively. The number of injections during weeks 52 through 96 was lower in the 2q4 and 2q8 groups versus the Rq4 group (differences of -0.64 [95{\%} CI, -0.89 to -0.40] and -0.55 [95{\%} CI, -0.79 to -0.30]; P < 0.0001, post hoc analysis). Incidences of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were similar across groups (2.4{\%} to 3.8{\%}) from baseline to week 96. Conclusions All aflibercept and ranibizumab groups were equally effective in improving BCVA and preventing BCVA loss at 96 weeks. The 2q8 aflibercept group was similar to ranibizumab in visual acuity outcomes during 96 weeks, but with an average of 5 fewer injections. Small losses at 96 weeks in the visual and anatomic gains seen at 52 weeks in all arms were in the range of losses commonly observed with variable dosing.",
author = "Ursula Schmidt-Erfurth and Kaiser, {Peter K.} and Korobelnik, {Jean Fran{\cc}ois} and Brown, {David M.} and Victor Chong and Nguyen, {Quan Dong} and Ho, {Allen C.} and Yuichiro Ogura and Christian Simader and Jaffe, {Glenn J.} and Slakter, {Jason S.} and Yancopoulos, {George D.} and Neil Stahl and Robert Vitti and Berliner, {Alyson J.} and Yuhwen Soo and Majid Anderesi and Olaf Sowade and Oliver Zeitz and Christiane Norenberg and Rupert Sandbrink and Heier, {Jeffrey S.}",
year = "2014",
month = "1",
day = "1",
doi = "10.1016/j.ophtha.2013.08.011",
language = "English (US)",
volume = "121",
pages = "193--201",
journal = "Ophthalmology",
issn = "0161-6420",
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TY - JOUR

T1 - Intravitreal aflibercept injection for neovascular age-related macular degeneration

T2 - Ninety-six-week results of the VIEW studies

AU - Schmidt-Erfurth, Ursula

AU - Kaiser, Peter K.

AU - Korobelnik, Jean François

AU - Brown, David M.

AU - Chong, Victor

AU - Nguyen, Quan Dong

AU - Ho, Allen C.

AU - Ogura, Yuichiro

AU - Simader, Christian

AU - Jaffe, Glenn J.

AU - Slakter, Jason S.

AU - Yancopoulos, George D.

AU - Stahl, Neil

AU - Vitti, Robert

AU - Berliner, Alyson J.

AU - Soo, Yuhwen

AU - Anderesi, Majid

AU - Sowade, Olaf

AU - Zeitz, Oliver

AU - Norenberg, Christiane

AU - Sandbrink, Rupert

AU - Heier, Jeffrey S.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Purpose To determine efficacy and safety of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) during a second year of variable dosing after a first-year fixed-dosing period. Design Two randomized, double-masked, active-controlled, phase 3 trials. Participants Two thousand four hundred fifty-seven patients with neovascular AMD. Methods From baseline to week 52, patients received 0.5 mg intravitreal ranibizumab every 4 weeks (Rq4), 2 mg aflibercept every 4 weeks (2q4), 0.5 mg aflibercept every 4 weeks (0.5q4), or 2 mg aflibercept every 8 weeks (2q8) after 3 monthly injections. During weeks 52 through 96, patients received their original dosing assignment using an as-needed regimen with defined retreatment criteria and mandatory dosing at least every 12 weeks. Main Outcome Measures Proportion of eyes at week 96 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA. Results Proportions of eyes maintaining BCVA across treatments were 94.4% to 96.1% at week 52 and 91.5% to 92.4% at week 96. Mean BCVA gains were 8.3 to 9.3 letters at week 52 and 6.6 to 7.9 letters at week 96. Proportions of eyes without retinal fluid decreased from week 52 (60.3% to 72.4%) to week 96 (44.6% to 54.4%), and more 2q4 eyes were without fluid at weeks 52 and 96 than Rq4 eyes (difference of 10.4% [95% confidence interval {CI}, 4.9-15.9] and 9.0% [95% CI, 3.0-15.1]). Patients received on average 16.5, 16.0, 16.2, and 11.2 injections over 96 weeks and 4.7, 4.1, 4.6, and 4.2 injections during weeks 52 through 96 in the Rq4, 2q4, 0.5q4, and 2q8 groups, respectively. The number of injections during weeks 52 through 96 was lower in the 2q4 and 2q8 groups versus the Rq4 group (differences of -0.64 [95% CI, -0.89 to -0.40] and -0.55 [95% CI, -0.79 to -0.30]; P < 0.0001, post hoc analysis). Incidences of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were similar across groups (2.4% to 3.8%) from baseline to week 96. Conclusions All aflibercept and ranibizumab groups were equally effective in improving BCVA and preventing BCVA loss at 96 weeks. The 2q8 aflibercept group was similar to ranibizumab in visual acuity outcomes during 96 weeks, but with an average of 5 fewer injections. Small losses at 96 weeks in the visual and anatomic gains seen at 52 weeks in all arms were in the range of losses commonly observed with variable dosing.

AB - Purpose To determine efficacy and safety of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) during a second year of variable dosing after a first-year fixed-dosing period. Design Two randomized, double-masked, active-controlled, phase 3 trials. Participants Two thousand four hundred fifty-seven patients with neovascular AMD. Methods From baseline to week 52, patients received 0.5 mg intravitreal ranibizumab every 4 weeks (Rq4), 2 mg aflibercept every 4 weeks (2q4), 0.5 mg aflibercept every 4 weeks (0.5q4), or 2 mg aflibercept every 8 weeks (2q8) after 3 monthly injections. During weeks 52 through 96, patients received their original dosing assignment using an as-needed regimen with defined retreatment criteria and mandatory dosing at least every 12 weeks. Main Outcome Measures Proportion of eyes at week 96 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA. Results Proportions of eyes maintaining BCVA across treatments were 94.4% to 96.1% at week 52 and 91.5% to 92.4% at week 96. Mean BCVA gains were 8.3 to 9.3 letters at week 52 and 6.6 to 7.9 letters at week 96. Proportions of eyes without retinal fluid decreased from week 52 (60.3% to 72.4%) to week 96 (44.6% to 54.4%), and more 2q4 eyes were without fluid at weeks 52 and 96 than Rq4 eyes (difference of 10.4% [95% confidence interval {CI}, 4.9-15.9] and 9.0% [95% CI, 3.0-15.1]). Patients received on average 16.5, 16.0, 16.2, and 11.2 injections over 96 weeks and 4.7, 4.1, 4.6, and 4.2 injections during weeks 52 through 96 in the Rq4, 2q4, 0.5q4, and 2q8 groups, respectively. The number of injections during weeks 52 through 96 was lower in the 2q4 and 2q8 groups versus the Rq4 group (differences of -0.64 [95% CI, -0.89 to -0.40] and -0.55 [95% CI, -0.79 to -0.30]; P < 0.0001, post hoc analysis). Incidences of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were similar across groups (2.4% to 3.8%) from baseline to week 96. Conclusions All aflibercept and ranibizumab groups were equally effective in improving BCVA and preventing BCVA loss at 96 weeks. The 2q8 aflibercept group was similar to ranibizumab in visual acuity outcomes during 96 weeks, but with an average of 5 fewer injections. Small losses at 96 weeks in the visual and anatomic gains seen at 52 weeks in all arms were in the range of losses commonly observed with variable dosing.

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