Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies

David M. Brown, Ursula Schmidt-Erfurth, Diana V. Do, Frank G. Holz, David S. Boyer, Edoardo Midena, Jeffrey S. Heier, Hiroko Terasaki, Peter K. Kaiser, 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, Jean François Korobelnik

Research output: Contribution to journalArticle

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Abstract

Purpose To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). Design Two similarly designed, randomized, phase 3 trials, VISTADME and VIVIDDME. Participants Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. Main Outcome Measures The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained 15 letters, and proportion of eyes with a 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Results Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained 15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost 15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a 2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control). Conclusions In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.

Original languageEnglish (US)
Pages (from-to)2044-2052
Number of pages9
JournalOphthalmology
Volume122
Issue number10
DOIs
StatePublished - Oct 1 2015

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Intravitreal Injections
Macular Edema
Lasers
Visual Acuity
Safety
Diabetic Retinopathy
aflibercept
Light Coagulation
Type 1 Diabetes Mellitus
Cataract
Type 2 Diabetes Mellitus
Outcome Assessment (Health Care)
Control Groups

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Brown, D. M., Schmidt-Erfurth, U., Do, D. V., Holz, F. G., Boyer, D. S., Midena, E., ... Korobelnik, J. F. (2015). Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology, 122(10), 2044-2052. https://doi.org/10.1016/j.ophtha.2015.06.017

Intravitreal aflibercept for diabetic macular edema : 100-week results from the VISTA and VIVID studies. / Brown, David M.; Schmidt-Erfurth, Ursula; Do, Diana V.; Holz, Frank G.; Boyer, David S.; Midena, Edoardo; Heier, Jeffrey S.; Terasaki, Hiroko; Kaiser, Peter K.; 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; Korobelnik, Jean François.

In: Ophthalmology, Vol. 122, No. 10, 01.10.2015, p. 2044-2052.

Research output: Contribution to journalArticle

Brown, DM, Schmidt-Erfurth, U, Do, DV, Holz, FG, Boyer, DS, Midena, E, Heier, JS, Terasaki, H, Kaiser, PK, 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 & Korobelnik, JF 2015, 'Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies', Ophthalmology, vol. 122, no. 10, pp. 2044-2052. https://doi.org/10.1016/j.ophtha.2015.06.017
Brown, David M. ; Schmidt-Erfurth, Ursula ; Do, Diana V. ; Holz, Frank G. ; Boyer, David S. ; Midena, Edoardo ; Heier, Jeffrey S. ; Terasaki, Hiroko ; Kaiser, Peter K. ; 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 ; Korobelnik, Jean François. / Intravitreal aflibercept for diabetic macular edema : 100-week results from the VISTA and VIVID studies. In: Ophthalmology. 2015 ; Vol. 122, No. 10. pp. 2044-2052.
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abstract = "Purpose To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). Design Two similarly designed, randomized, phase 3 trials, VISTADME and VIVIDDME. Participants Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. Main Outcome Measures The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained 15 letters, and proportion of eyes with a 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Results Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained 15 letters from baseline at week 100 was 38.3{\%}, 33.1{\%}, and 13.0{\%} (P < 0.0001) in VISTA and 38.2{\%}, 31.1{\%}, and 12.1{\%} (P ≤ 0.0001) in VIVID. The proportion of eyes that lost 15 letters at week 100 was 3.2{\%}, 0.7{\%}, and 9.7{\%} (P ≤ 0.0220) in VISTA and 2.2{\%}, 1.5{\%}, and 12.9{\%} (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a 2 step improvement in the DRSS score in both VISTA (37.0{\%} and 37.1{\%} vs. 15.6{\%}; P < 0.0001) and VIVID (29.3{\%} and 32.6{\%} vs. 8.2{\%}; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4{\%}, 1.0{\%}, and 0.3{\%} for 2q4, 2q8, and control). Conclusions In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.",
author = "Brown, {David M.} and Ursula Schmidt-Erfurth and Do, {Diana V.} and Holz, {Frank G.} and Boyer, {David S.} and Edoardo Midena and Heier, {Jeffrey S.} and Hiroko Terasaki and Kaiser, {Peter K.} 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 Korobelnik, {Jean Fran{\cc}ois}",
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month = "10",
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doi = "10.1016/j.ophtha.2015.06.017",
language = "English (US)",
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TY - JOUR

T1 - Intravitreal aflibercept for diabetic macular edema

T2 - 100-week results from the VISTA and VIVID studies

AU - Brown, David M.

AU - Schmidt-Erfurth, Ursula

AU - Do, Diana V.

AU - Holz, Frank G.

AU - Boyer, David S.

AU - Midena, Edoardo

AU - Heier, Jeffrey S.

AU - Terasaki, Hiroko

AU - Kaiser, Peter K.

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 - Korobelnik, Jean François

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Purpose To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). Design Two similarly designed, randomized, phase 3 trials, VISTADME and VIVIDDME. Participants Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. Main Outcome Measures The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained 15 letters, and proportion of eyes with a 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Results Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained 15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost 15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a 2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control). Conclusions In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.

AB - Purpose To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). Design Two similarly designed, randomized, phase 3 trials, VISTADME and VIVIDDME. Participants Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. Main Outcome Measures The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained 15 letters, and proportion of eyes with a 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Results Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained 15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost 15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a 2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control). Conclusions In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.

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