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Evaluating the Impact of Intravitreal Aflibercept on Diabetic Retinopathy Progression in the VIVID-DME and VISTA-DME Studies

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Harvard

Mitchell, P, McAllister, I, Larsen, M, Staurenghi, G, Korobelnik, JF, Boyer, DS, Do, DV, Brown, DM, Katz, TA, Berliner, A, Vitti, R, Zeitz, O, Metzig, C, Lu, C & Holz, FG 2018, 'Evaluating the Impact of Intravitreal Aflibercept on Diabetic Retinopathy Progression in the VIVID-DME and VISTA-DME Studies', Ophthalmology Retina, vol. 2, no. 10, pp. 988-996. https://doi.org/10.1016/j.oret.2018.02.011

APA

Mitchell, P., McAllister, I., Larsen, M., Staurenghi, G., Korobelnik, J. F., Boyer, D. S., Do, D. V., Brown, D. M., Katz, T. A., Berliner, A., Vitti, R., Zeitz, O., Metzig, C., Lu, C., & Holz, F. G. (2018). Evaluating the Impact of Intravitreal Aflibercept on Diabetic Retinopathy Progression in the VIVID-DME and VISTA-DME Studies. Ophthalmology Retina, 2(10), 988-996. https://doi.org/10.1016/j.oret.2018.02.011

CBE

Mitchell P, McAllister I, Larsen M, Staurenghi G, Korobelnik JF, Boyer DS, Do DV, Brown DM, Katz TA, Berliner A, Vitti R, Zeitz O, Metzig C, Lu C, Holz FG. 2018. Evaluating the Impact of Intravitreal Aflibercept on Diabetic Retinopathy Progression in the VIVID-DME and VISTA-DME Studies. Ophthalmology Retina. 2(10):988-996. https://doi.org/10.1016/j.oret.2018.02.011

MLA

Vancouver

Author

Mitchell, Paul ; McAllister, Ian ; Larsen, Michael ; Staurenghi, Giovanni ; Korobelnik, Jean Francois ; Boyer, David S. ; Do, Diana V. ; Brown, David M. ; Katz, Todd A. ; Berliner, Alyson ; Vitti, Robert ; Zeitz, Oliver ; Metzig, Carola ; Lu, Chengxing ; Holz, Frank G. / Evaluating the Impact of Intravitreal Aflibercept on Diabetic Retinopathy Progression in the VIVID-DME and VISTA-DME Studies. In: Ophthalmology Retina. 2018 ; Vol. 2, No. 10. pp. 988-996.

Bibtex

@article{07b708b08233460cbb090304a98d1fbd,
title = "Evaluating the Impact of Intravitreal Aflibercept on Diabetic Retinopathy Progression in the VIVID-DME and VISTA-DME Studies",
abstract = "Purpose: To evaluate the impact of intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Tarrytown, NY) versus laser on progression of diabetic retinopathy (DR) severity in Intravitreal Aflibercept Injection in Vision Impairment due to DME (VIVID-DME) and Study of Intravitreal Aflibercept Injection in Patients with Diabetic Macular Edema (VISTA-DME). Design: Secondary and exploratory analyses of 2 phase 3, randomized, controlled studies. Participants: All patients with a baseline Diabetic Retinopathy Severity Scale (DRSS) score based on fundus photograph (full analysis), patients who progressed to proliferative DR (PDR) (safety analysis) in VIVID-DME (n = 403) and VISTA-DME (n = 459), or both. Methods: We randomized patients with diabetic macular edema (DME) to intravitreal aflibercept 2 mg every 4 weeks (2q4), intravitreal aflibercept 2 mg every 8 weeks after 5 initial monthly doses (2q8), or macular laser photocoagulation at baseline and sham injections at every visit. Main Outcome Measures: Proportions of patients with 2-step or more and 3-step or more improvements from baseline in DRSS score, who progressed to PDR, and who underwent panretinal photocoagulation (PRP). Results: Among patients with an assessable baseline DRSS score, most showed moderately severe or severe nonproliferative DR. The proportions of patients treated with 2q4, 2q8, and laser with a 2-step or more improvement in DRSS score at week 100 were 29.3%, 32.6%, and 8.2%, respectively, in VIVID-DME and 37.0%, 37.1%, and 15.6%, respectively, in VISTA-DME; the proportions with a 3-step or more improvement in DRSS score were 7.3%, 2.3%, and 0%, respectively, and 22.7%, 19.9%, and 5.2%, respectively. Fewer patients in the 2q4 and 2q8 groups versus the laser group progressed to PDR at week 100 in VISTA-DME (1.5% and 2.2% vs. 5.3%) and VIVID-DME (3.2% and 2.0% vs. 12.3%). The proportions of patients who underwent PRP were 2.9%, 0.7%, and 4.5%, respectively, in VIVID-DME and 1.9%, 0.7%, and 5.2%, respectively, in VISTA-DME. The most frequent serious ocular adverse event at week 100 was cataract (pooled intravitreal aflibercept, 1.7% of patients; laser, 3.5% of patients). Conclusions: These analyses demonstrate the benefit of intravitreal aflibercept over laser with respect to DR progression, suggesting a benefit on DME, and on underlying DR.",
author = "Paul Mitchell and Ian McAllister and Michael Larsen and Giovanni Staurenghi and Korobelnik, {Jean Francois} and Boyer, {David S.} and Do, {Diana V.} and Brown, {David M.} and Katz, {Todd A.} and Alyson Berliner and Robert Vitti and Oliver Zeitz and Carola Metzig and Chengxing Lu and Holz, {Frank G.}",
year = "2018",
month = oct,
day = "1",
doi = "10.1016/j.oret.2018.02.011",
language = "English",
volume = "2",
pages = "988--996",
journal = "Ophthalmology Retina",
issn = "2468-7219",
publisher = "Elsevier Inc.",
number = "10",

}

RIS

TY - JOUR

T1 - Evaluating the Impact of Intravitreal Aflibercept on Diabetic Retinopathy Progression in the VIVID-DME and VISTA-DME Studies

AU - Mitchell, Paul

AU - McAllister, Ian

AU - Larsen, Michael

AU - Staurenghi, Giovanni

AU - Korobelnik, Jean Francois

AU - Boyer, David S.

AU - Do, Diana V.

AU - Brown, David M.

AU - Katz, Todd A.

AU - Berliner, Alyson

AU - Vitti, Robert

AU - Zeitz, Oliver

AU - Metzig, Carola

AU - Lu, Chengxing

AU - Holz, Frank G.

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Purpose: To evaluate the impact of intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Tarrytown, NY) versus laser on progression of diabetic retinopathy (DR) severity in Intravitreal Aflibercept Injection in Vision Impairment due to DME (VIVID-DME) and Study of Intravitreal Aflibercept Injection in Patients with Diabetic Macular Edema (VISTA-DME). Design: Secondary and exploratory analyses of 2 phase 3, randomized, controlled studies. Participants: All patients with a baseline Diabetic Retinopathy Severity Scale (DRSS) score based on fundus photograph (full analysis), patients who progressed to proliferative DR (PDR) (safety analysis) in VIVID-DME (n = 403) and VISTA-DME (n = 459), or both. Methods: We randomized patients with diabetic macular edema (DME) to intravitreal aflibercept 2 mg every 4 weeks (2q4), intravitreal aflibercept 2 mg every 8 weeks after 5 initial monthly doses (2q8), or macular laser photocoagulation at baseline and sham injections at every visit. Main Outcome Measures: Proportions of patients with 2-step or more and 3-step or more improvements from baseline in DRSS score, who progressed to PDR, and who underwent panretinal photocoagulation (PRP). Results: Among patients with an assessable baseline DRSS score, most showed moderately severe or severe nonproliferative DR. The proportions of patients treated with 2q4, 2q8, and laser with a 2-step or more improvement in DRSS score at week 100 were 29.3%, 32.6%, and 8.2%, respectively, in VIVID-DME and 37.0%, 37.1%, and 15.6%, respectively, in VISTA-DME; the proportions with a 3-step or more improvement in DRSS score were 7.3%, 2.3%, and 0%, respectively, and 22.7%, 19.9%, and 5.2%, respectively. Fewer patients in the 2q4 and 2q8 groups versus the laser group progressed to PDR at week 100 in VISTA-DME (1.5% and 2.2% vs. 5.3%) and VIVID-DME (3.2% and 2.0% vs. 12.3%). The proportions of patients who underwent PRP were 2.9%, 0.7%, and 4.5%, respectively, in VIVID-DME and 1.9%, 0.7%, and 5.2%, respectively, in VISTA-DME. The most frequent serious ocular adverse event at week 100 was cataract (pooled intravitreal aflibercept, 1.7% of patients; laser, 3.5% of patients). Conclusions: These analyses demonstrate the benefit of intravitreal aflibercept over laser with respect to DR progression, suggesting a benefit on DME, and on underlying DR.

AB - Purpose: To evaluate the impact of intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Tarrytown, NY) versus laser on progression of diabetic retinopathy (DR) severity in Intravitreal Aflibercept Injection in Vision Impairment due to DME (VIVID-DME) and Study of Intravitreal Aflibercept Injection in Patients with Diabetic Macular Edema (VISTA-DME). Design: Secondary and exploratory analyses of 2 phase 3, randomized, controlled studies. Participants: All patients with a baseline Diabetic Retinopathy Severity Scale (DRSS) score based on fundus photograph (full analysis), patients who progressed to proliferative DR (PDR) (safety analysis) in VIVID-DME (n = 403) and VISTA-DME (n = 459), or both. Methods: We randomized patients with diabetic macular edema (DME) to intravitreal aflibercept 2 mg every 4 weeks (2q4), intravitreal aflibercept 2 mg every 8 weeks after 5 initial monthly doses (2q8), or macular laser photocoagulation at baseline and sham injections at every visit. Main Outcome Measures: Proportions of patients with 2-step or more and 3-step or more improvements from baseline in DRSS score, who progressed to PDR, and who underwent panretinal photocoagulation (PRP). Results: Among patients with an assessable baseline DRSS score, most showed moderately severe or severe nonproliferative DR. The proportions of patients treated with 2q4, 2q8, and laser with a 2-step or more improvement in DRSS score at week 100 were 29.3%, 32.6%, and 8.2%, respectively, in VIVID-DME and 37.0%, 37.1%, and 15.6%, respectively, in VISTA-DME; the proportions with a 3-step or more improvement in DRSS score were 7.3%, 2.3%, and 0%, respectively, and 22.7%, 19.9%, and 5.2%, respectively. Fewer patients in the 2q4 and 2q8 groups versus the laser group progressed to PDR at week 100 in VISTA-DME (1.5% and 2.2% vs. 5.3%) and VIVID-DME (3.2% and 2.0% vs. 12.3%). The proportions of patients who underwent PRP were 2.9%, 0.7%, and 4.5%, respectively, in VIVID-DME and 1.9%, 0.7%, and 5.2%, respectively, in VISTA-DME. The most frequent serious ocular adverse event at week 100 was cataract (pooled intravitreal aflibercept, 1.7% of patients; laser, 3.5% of patients). Conclusions: These analyses demonstrate the benefit of intravitreal aflibercept over laser with respect to DR progression, suggesting a benefit on DME, and on underlying DR.

UR - http://www.scopus.com/inward/record.url?scp=85055892434&partnerID=8YFLogxK

U2 - 10.1016/j.oret.2018.02.011

DO - 10.1016/j.oret.2018.02.011

M3 - Journal article

AN - SCOPUS:85055892434

VL - 2

SP - 988

EP - 996

JO - Ophthalmology Retina

JF - Ophthalmology Retina

SN - 2468-7219

IS - 10

ER -

ID: 59451747