Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies

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

Research output: Contribution to journalArticle

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Abstract

Purpose To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years. Design Two similarly designed phase 3 trials: VISTADME and VIVIDDME. Participants Patients (eyes; n = 872) with central-involved DME. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. From week 100, laser control patients who had not received IAI rescue treatment received IAI as needed per retreatment criteria. Main Outcome Measures The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 52. We report the 148-week results. Results Mean BCVA gain from baseline to week 148 with IAI 2q4, IAI 2q8, and laser control was 10.4, 10.5, and 1.4 letters (P < 0.0001) in VISTA and 10.3, 11.7, and 1.6 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 148 was 42.9%, 35.8%, and 13.6% (P < 0.0001) in VISTA and 41.2%, 42.2%, and 18.9% (P < 0.0001) in VIVID, respectively. Greater proportions of eyes treated with IAI 2q4 and IAI 2q8 versus those treated with laser control had an improvement of ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score in both VISTA (29.9% and 34.4% vs. 20.1% [P = 0.0350, IAI 2q4; P = 0.0052, IAI 2q8]) and VIVID (44.3% and 47.8% vs. 17.4% [P < 0.0001 for both]). In an integrated safety analysis, the most frequent ocular serious adverse event was cataract (3.1%, 2.1%, 0.3% for 2q4, 2q8, and control). Conclusions Visual improvements observed with both IAI regimens (over laser control) at weeks 52 and 100 were maintained at week 148, with similar overall efficacy in the IAI 2q4 and IAI 2q8 groups. Treatment with IAI also had positive effects on the DRSS score. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.

Original languageEnglish (US)
Pages (from-to)2376-2385
Number of pages10
JournalOphthalmology
Volume123
Issue number11
DOIs
StatePublished - Nov 1 2016

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Intravitreal Injections
Macular Edema
Lasers
aflibercept
Diabetic Retinopathy
Safety
Visual Acuity
Retreatment
Light Coagulation

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Heier, J. S., Korobelnik, J. F., Brown, D. M., Schmidt-Erfurth, U., Do, D. V., Midena, E., ... Holz, F. G. (2016). Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology, 123(11), 2376-2385. https://doi.org/10.1016/j.ophtha.2016.07.032

Intravitreal Aflibercept for Diabetic Macular Edema : 148-Week Results from the VISTA and VIVID Studies. / Heier, Jeffrey S.; Korobelnik, Jean François; Brown, David M.; Schmidt-Erfurth, Ursula; Do, Diana V.; Midena, Edoardo; Boyer, David S.; Terasaki, Hiroko; Kaiser, Peter K.; Marcus, Dennis M.; Nguyen, Quan D.; Jaffe, Glenn J.; Slakter, Jason S.; Simader, Christian; Soo, Yuhwen; Schmelter, Thomas; Vitti, Robert; Berliner, Alyson J.; Zeitz, Oliver; Metzig, Carola; Holz, Frank G.

In: Ophthalmology, Vol. 123, No. 11, 01.11.2016, p. 2376-2385.

Research output: Contribution to journalArticle

Heier, JS, Korobelnik, JF, Brown, DM, Schmidt-Erfurth, U, Do, DV, Midena, E, Boyer, DS, Terasaki, H, Kaiser, PK, Marcus, DM, Nguyen, QD, Jaffe, GJ, Slakter, JS, Simader, C, Soo, Y, Schmelter, T, Vitti, R, Berliner, AJ, Zeitz, O, Metzig, C & Holz, FG 2016, 'Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies', Ophthalmology, vol. 123, no. 11, pp. 2376-2385. https://doi.org/10.1016/j.ophtha.2016.07.032
Heier JS, Korobelnik JF, Brown DM, Schmidt-Erfurth U, Do DV, Midena E et al. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016 Nov 1;123(11):2376-2385. https://doi.org/10.1016/j.ophtha.2016.07.032
Heier, Jeffrey S. ; Korobelnik, Jean François ; Brown, David M. ; Schmidt-Erfurth, Ursula ; Do, Diana V. ; Midena, Edoardo ; Boyer, David S. ; Terasaki, Hiroko ; Kaiser, Peter K. ; Marcus, Dennis M. ; Nguyen, Quan D. ; Jaffe, Glenn J. ; Slakter, Jason S. ; Simader, Christian ; Soo, Yuhwen ; Schmelter, Thomas ; Vitti, Robert ; Berliner, Alyson J. ; Zeitz, Oliver ; Metzig, Carola ; Holz, Frank G. / Intravitreal Aflibercept for Diabetic Macular Edema : 148-Week Results from the VISTA and VIVID Studies. In: Ophthalmology. 2016 ; Vol. 123, No. 11. pp. 2376-2385.
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title = "Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies",
abstract = "Purpose To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years. Design Two similarly designed phase 3 trials: VISTADME and VIVIDDME. Participants Patients (eyes; n = 872) with central-involved DME. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. From week 100, laser control patients who had not received IAI rescue treatment received IAI as needed per retreatment criteria. Main Outcome Measures The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 52. We report the 148-week results. Results Mean BCVA gain from baseline to week 148 with IAI 2q4, IAI 2q8, and laser control was 10.4, 10.5, and 1.4 letters (P < 0.0001) in VISTA and 10.3, 11.7, and 1.6 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 148 was 42.9{\%}, 35.8{\%}, and 13.6{\%} (P < 0.0001) in VISTA and 41.2{\%}, 42.2{\%}, and 18.9{\%} (P < 0.0001) in VIVID, respectively. Greater proportions of eyes treated with IAI 2q4 and IAI 2q8 versus those treated with laser control had an improvement of ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score in both VISTA (29.9{\%} and 34.4{\%} vs. 20.1{\%} [P = 0.0350, IAI 2q4; P = 0.0052, IAI 2q8]) and VIVID (44.3{\%} and 47.8{\%} vs. 17.4{\%} [P < 0.0001 for both]). In an integrated safety analysis, the most frequent ocular serious adverse event was cataract (3.1{\%}, 2.1{\%}, 0.3{\%} for 2q4, 2q8, and control). Conclusions Visual improvements observed with both IAI regimens (over laser control) at weeks 52 and 100 were maintained at week 148, with similar overall efficacy in the IAI 2q4 and IAI 2q8 groups. Treatment with IAI also had positive effects on the DRSS score. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.",
author = "Heier, {Jeffrey S.} and Korobelnik, {Jean Fran{\cc}ois} and Brown, {David M.} and Ursula Schmidt-Erfurth and Do, {Diana V.} and Edoardo Midena and Boyer, {David 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 Robert Vitti and Berliner, {Alyson J.} and Oliver Zeitz and Carola Metzig and Holz, {Frank G.}",
year = "2016",
month = "11",
day = "1",
doi = "10.1016/j.ophtha.2016.07.032",
language = "English (US)",
volume = "123",
pages = "2376--2385",
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TY - JOUR

T1 - Intravitreal Aflibercept for Diabetic Macular Edema

T2 - 148-Week Results from the VISTA and VIVID Studies

AU - Heier, Jeffrey S.

AU - Korobelnik, Jean François

AU - Brown, David M.

AU - Schmidt-Erfurth, Ursula

AU - Do, Diana V.

AU - Midena, Edoardo

AU - Boyer, David 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 - Vitti, Robert

AU - Berliner, Alyson J.

AU - Zeitz, Oliver

AU - Metzig, Carola

AU - Holz, Frank G.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Purpose To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years. Design Two similarly designed phase 3 trials: VISTADME and VIVIDDME. Participants Patients (eyes; n = 872) with central-involved DME. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. From week 100, laser control patients who had not received IAI rescue treatment received IAI as needed per retreatment criteria. Main Outcome Measures The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 52. We report the 148-week results. Results Mean BCVA gain from baseline to week 148 with IAI 2q4, IAI 2q8, and laser control was 10.4, 10.5, and 1.4 letters (P < 0.0001) in VISTA and 10.3, 11.7, and 1.6 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 148 was 42.9%, 35.8%, and 13.6% (P < 0.0001) in VISTA and 41.2%, 42.2%, and 18.9% (P < 0.0001) in VIVID, respectively. Greater proportions of eyes treated with IAI 2q4 and IAI 2q8 versus those treated with laser control had an improvement of ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score in both VISTA (29.9% and 34.4% vs. 20.1% [P = 0.0350, IAI 2q4; P = 0.0052, IAI 2q8]) and VIVID (44.3% and 47.8% vs. 17.4% [P < 0.0001 for both]). In an integrated safety analysis, the most frequent ocular serious adverse event was cataract (3.1%, 2.1%, 0.3% for 2q4, 2q8, and control). Conclusions Visual improvements observed with both IAI regimens (over laser control) at weeks 52 and 100 were maintained at week 148, with similar overall efficacy in the IAI 2q4 and IAI 2q8 groups. Treatment with IAI also had positive effects on the DRSS score. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.

AB - Purpose To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years. Design Two similarly designed phase 3 trials: VISTADME and VIVIDDME. Participants Patients (eyes; n = 872) with central-involved DME. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. From week 100, laser control patients who had not received IAI rescue treatment received IAI as needed per retreatment criteria. Main Outcome Measures The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 52. We report the 148-week results. Results Mean BCVA gain from baseline to week 148 with IAI 2q4, IAI 2q8, and laser control was 10.4, 10.5, and 1.4 letters (P < 0.0001) in VISTA and 10.3, 11.7, and 1.6 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 148 was 42.9%, 35.8%, and 13.6% (P < 0.0001) in VISTA and 41.2%, 42.2%, and 18.9% (P < 0.0001) in VIVID, respectively. Greater proportions of eyes treated with IAI 2q4 and IAI 2q8 versus those treated with laser control had an improvement of ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score in both VISTA (29.9% and 34.4% vs. 20.1% [P = 0.0350, IAI 2q4; P = 0.0052, IAI 2q8]) and VIVID (44.3% and 47.8% vs. 17.4% [P < 0.0001 for both]). In an integrated safety analysis, the most frequent ocular serious adverse event was cataract (3.1%, 2.1%, 0.3% for 2q4, 2q8, and control). Conclusions Visual improvements observed with both IAI regimens (over laser control) at weeks 52 and 100 were maintained at week 148, with similar overall efficacy in the IAI 2q4 and IAI 2q8 groups. Treatment with IAI also had positive effects on the DRSS score. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.

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