Comparison of monthly vs treat-and-extend regimens for individuals with macular edema who respond well to anti-vascular endothelial growth factor medications: Secondary outcomes from the SCORE2 randomized clinical trial

SCORE2 Investigator Group

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

IMPORTANCE Comparisons of monthly vs treat-and-extend anti-vascular endothelial growth factor (anti-VEGF) regimens for macular edema from central retinal vein occlusion or hemiretinal vein occlusion is needed. OBJECTIVE To compare visual acuity letter score and central subfield thickness outcomes of participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial who then received either monthly injections or treat-and-extend (TAE) regimens of aflibercept or bevacizumab after a good response at month 6. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial enrolled participants from 66 private practice or academic centers in the United States. All participants had macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, had enrolled in the SCORE2 trial, and had a protocol-defined good response to monthly injections in the first 6 months of the trial. Participants initially assigned to receive monthly aflibercept were randomized to aflibercept on a monthly or TAE schedule, and participants initially assigned to receive monthly injections of bevacizumab were randomized to receive bevacizumab on a monthly or TAE schedule. The first participant was randomized in the SCORE2 trial on September 17, 2014, and the last month 12 visit occurred on October 24, 2016. MAIN OUTCOMES AND MEASURES Change from month 6 to month 12 in best-corrected electronic visual acuity letter score (per the Early Treatment Diabetic Retinopathy Study). RESULTS The 293 participants had a mean (SD) age of 68.9 (11.9) years; 127 (43.3%) were female. Of these, 79 were randomized to aflibercept on a monthly schedule, 80 to aflibercept on a TAE schedule, 67 to monthly bevacizumab, and 67 to bevacizumab on a TAE schedule. Mean treatment group difference (the change in visual acuity letter score in the monthly group minus the change in the TAE group) from month 6 to month 12 was 1.88 (97.5%CI, -1.07 to 4.83; P = .15) for aflibercept and 1.98 (97.5%CI, -1.08 to 5.03; P = .15) for bevacizumab. In the aflibercept arm, the mean number of injections between months 6 and 11 was 5.8 in the monthly injection group (95%CI, 5.6 to 5.9) and 3.8 in the TAE group (95% CI, 3.5 to 4.1; P < .001); in the bevacizumab arm, the mean number of injections was 5.8 (95% CI, 5.6 to 5.9) in the monthly group and 4.5 in the TAE group (95%CI, 4.2 to 4.8; P < .001). CONCLUSIONS AND RELEVANCE One to 2 fewer injections of aflibercept or bevacizumab were given to the TAE groups than the monthly groups in months 6 to 12 for macular edema associated with central retinal or hemiretinal vein occlusion. Because of wide confidence intervals on the differences between the groups, caution is warranted before concluding that the regimens are associated with similar vision outcomes.

Original languageEnglish (US)
Pages (from-to)337-345
Number of pages9
JournalJAMA Ophthalmology
Volume136
Issue number4
DOIs
StatePublished - Apr 2018

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Macular Edema
Vascular Endothelial Growth Factor A
Randomized Controlled Trials
Injections
Appointments and Schedules
Retinal Vein Occlusion
Visual Acuity
Retinal Vein
Veins
Bevacizumab
aflibercept
Private Practice
Diabetic Retinopathy
Therapeutics
Outcome Assessment (Health Care)
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

@article{3b5998c09a8c4313aa5e791ed6b480e7,
title = "Comparison of monthly vs treat-and-extend regimens for individuals with macular edema who respond well to anti-vascular endothelial growth factor medications: Secondary outcomes from the SCORE2 randomized clinical trial",
abstract = "IMPORTANCE Comparisons of monthly vs treat-and-extend anti-vascular endothelial growth factor (anti-VEGF) regimens for macular edema from central retinal vein occlusion or hemiretinal vein occlusion is needed. OBJECTIVE To compare visual acuity letter score and central subfield thickness outcomes of participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial who then received either monthly injections or treat-and-extend (TAE) regimens of aflibercept or bevacizumab after a good response at month 6. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial enrolled participants from 66 private practice or academic centers in the United States. All participants had macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, had enrolled in the SCORE2 trial, and had a protocol-defined good response to monthly injections in the first 6 months of the trial. Participants initially assigned to receive monthly aflibercept were randomized to aflibercept on a monthly or TAE schedule, and participants initially assigned to receive monthly injections of bevacizumab were randomized to receive bevacizumab on a monthly or TAE schedule. The first participant was randomized in the SCORE2 trial on September 17, 2014, and the last month 12 visit occurred on October 24, 2016. MAIN OUTCOMES AND MEASURES Change from month 6 to month 12 in best-corrected electronic visual acuity letter score (per the Early Treatment Diabetic Retinopathy Study). RESULTS The 293 participants had a mean (SD) age of 68.9 (11.9) years; 127 (43.3{\%}) were female. Of these, 79 were randomized to aflibercept on a monthly schedule, 80 to aflibercept on a TAE schedule, 67 to monthly bevacizumab, and 67 to bevacizumab on a TAE schedule. Mean treatment group difference (the change in visual acuity letter score in the monthly group minus the change in the TAE group) from month 6 to month 12 was 1.88 (97.5{\%}CI, -1.07 to 4.83; P = .15) for aflibercept and 1.98 (97.5{\%}CI, -1.08 to 5.03; P = .15) for bevacizumab. In the aflibercept arm, the mean number of injections between months 6 and 11 was 5.8 in the monthly injection group (95{\%}CI, 5.6 to 5.9) and 3.8 in the TAE group (95{\%} CI, 3.5 to 4.1; P < .001); in the bevacizumab arm, the mean number of injections was 5.8 (95{\%} CI, 5.6 to 5.9) in the monthly group and 4.5 in the TAE group (95{\%}CI, 4.2 to 4.8; P < .001). CONCLUSIONS AND RELEVANCE One to 2 fewer injections of aflibercept or bevacizumab were given to the TAE groups than the monthly groups in months 6 to 12 for macular edema associated with central retinal or hemiretinal vein occlusion. Because of wide confidence intervals on the differences between the groups, caution is warranted before concluding that the regimens are associated with similar vision outcomes.",
author = "{SCORE2 Investigator Group} and Scott, {Ingrid U.} and VanVeldhuisen, {Paul C.} and Ip, {Michael S.} and Blodi, {Barbara A.} and Oden, {Neal L.} and Michael Altaweel and Berinstein, {Daniel M.} and Sangeeta Bhargava and Figueroa, {Maria J.} and Musch, {David C.} and Han, {Dennis P.} and Sadda, {Srinivas R.} and Williams, {George A.} and Stephen Wisniewski and Janelle Gaston and Lena Bradley and {De Stefano}, Jodi and Eileen Guan and Anne Hoehn and Alexa Irazabal and Sue Isman and Jacquie King and Radhika Kondapaka and Hamsa Kumar and Matt Lahut and Robert Lindblad and Neal Oden and Michael Patschak and Rothwell, {Ro Shauna} and Rosemary Smith and {Van Dyke}, Janet and Valerie Watson and Lauren Yesko and Amitha Domalpally and Susan Reed and Pam Vargo and Cynthia Reed and Prema Abraham and Beth Bement-Stump and Leah Callahan and Mindi Dockter and Kristi Livermont and Robert Nixon and Dan Parks and Nathan Steinle and Alison Thompson and Stephen Khachikian and Steven Bailey and Jordan Barth and Campbell, {J. Peter}",
year = "2018",
month = "4",
doi = "10.1001/jamaophthalmol.2017.6843",
language = "English (US)",
volume = "136",
pages = "337--345",
journal = "JAMA Ophthalmology",
issn = "2168-6165",
publisher = "American Medical Association",
number = "4",

}

TY - JOUR

T1 - Comparison of monthly vs treat-and-extend regimens for individuals with macular edema who respond well to anti-vascular endothelial growth factor medications

T2 - Secondary outcomes from the SCORE2 randomized clinical trial

AU - SCORE2 Investigator Group

AU - Scott, Ingrid U.

AU - VanVeldhuisen, Paul C.

AU - Ip, Michael S.

AU - Blodi, Barbara A.

AU - Oden, Neal L.

AU - Altaweel, Michael

AU - Berinstein, Daniel M.

AU - Bhargava, Sangeeta

AU - Figueroa, Maria J.

AU - Musch, David C.

AU - Han, Dennis P.

AU - Sadda, Srinivas R.

AU - Williams, George A.

AU - Wisniewski, Stephen

AU - Gaston, Janelle

AU - Bradley, Lena

AU - De Stefano, Jodi

AU - Guan, Eileen

AU - Hoehn, Anne

AU - Irazabal, Alexa

AU - Isman, Sue

AU - King, Jacquie

AU - Kondapaka, Radhika

AU - Kumar, Hamsa

AU - Lahut, Matt

AU - Lindblad, Robert

AU - Oden, Neal

AU - Patschak, Michael

AU - Rothwell, Ro Shauna

AU - Smith, Rosemary

AU - Van Dyke, Janet

AU - Watson, Valerie

AU - Yesko, Lauren

AU - Domalpally, Amitha

AU - Reed, Susan

AU - Vargo, Pam

AU - Reed, Cynthia

AU - Abraham, Prema

AU - Bement-Stump, Beth

AU - Callahan, Leah

AU - Dockter, Mindi

AU - Livermont, Kristi

AU - Nixon, Robert

AU - Parks, Dan

AU - Steinle, Nathan

AU - Thompson, Alison

AU - Khachikian, Stephen

AU - Bailey, Steven

AU - Barth, Jordan

AU - Campbell, J. Peter

PY - 2018/4

Y1 - 2018/4

N2 - IMPORTANCE Comparisons of monthly vs treat-and-extend anti-vascular endothelial growth factor (anti-VEGF) regimens for macular edema from central retinal vein occlusion or hemiretinal vein occlusion is needed. OBJECTIVE To compare visual acuity letter score and central subfield thickness outcomes of participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial who then received either monthly injections or treat-and-extend (TAE) regimens of aflibercept or bevacizumab after a good response at month 6. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial enrolled participants from 66 private practice or academic centers in the United States. All participants had macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, had enrolled in the SCORE2 trial, and had a protocol-defined good response to monthly injections in the first 6 months of the trial. Participants initially assigned to receive monthly aflibercept were randomized to aflibercept on a monthly or TAE schedule, and participants initially assigned to receive monthly injections of bevacizumab were randomized to receive bevacizumab on a monthly or TAE schedule. The first participant was randomized in the SCORE2 trial on September 17, 2014, and the last month 12 visit occurred on October 24, 2016. MAIN OUTCOMES AND MEASURES Change from month 6 to month 12 in best-corrected electronic visual acuity letter score (per the Early Treatment Diabetic Retinopathy Study). RESULTS The 293 participants had a mean (SD) age of 68.9 (11.9) years; 127 (43.3%) were female. Of these, 79 were randomized to aflibercept on a monthly schedule, 80 to aflibercept on a TAE schedule, 67 to monthly bevacizumab, and 67 to bevacizumab on a TAE schedule. Mean treatment group difference (the change in visual acuity letter score in the monthly group minus the change in the TAE group) from month 6 to month 12 was 1.88 (97.5%CI, -1.07 to 4.83; P = .15) for aflibercept and 1.98 (97.5%CI, -1.08 to 5.03; P = .15) for bevacizumab. In the aflibercept arm, the mean number of injections between months 6 and 11 was 5.8 in the monthly injection group (95%CI, 5.6 to 5.9) and 3.8 in the TAE group (95% CI, 3.5 to 4.1; P < .001); in the bevacizumab arm, the mean number of injections was 5.8 (95% CI, 5.6 to 5.9) in the monthly group and 4.5 in the TAE group (95%CI, 4.2 to 4.8; P < .001). CONCLUSIONS AND RELEVANCE One to 2 fewer injections of aflibercept or bevacizumab were given to the TAE groups than the monthly groups in months 6 to 12 for macular edema associated with central retinal or hemiretinal vein occlusion. Because of wide confidence intervals on the differences between the groups, caution is warranted before concluding that the regimens are associated with similar vision outcomes.

AB - IMPORTANCE Comparisons of monthly vs treat-and-extend anti-vascular endothelial growth factor (anti-VEGF) regimens for macular edema from central retinal vein occlusion or hemiretinal vein occlusion is needed. OBJECTIVE To compare visual acuity letter score and central subfield thickness outcomes of participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial who then received either monthly injections or treat-and-extend (TAE) regimens of aflibercept or bevacizumab after a good response at month 6. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial enrolled participants from 66 private practice or academic centers in the United States. All participants had macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, had enrolled in the SCORE2 trial, and had a protocol-defined good response to monthly injections in the first 6 months of the trial. Participants initially assigned to receive monthly aflibercept were randomized to aflibercept on a monthly or TAE schedule, and participants initially assigned to receive monthly injections of bevacizumab were randomized to receive bevacizumab on a monthly or TAE schedule. The first participant was randomized in the SCORE2 trial on September 17, 2014, and the last month 12 visit occurred on October 24, 2016. MAIN OUTCOMES AND MEASURES Change from month 6 to month 12 in best-corrected electronic visual acuity letter score (per the Early Treatment Diabetic Retinopathy Study). RESULTS The 293 participants had a mean (SD) age of 68.9 (11.9) years; 127 (43.3%) were female. Of these, 79 were randomized to aflibercept on a monthly schedule, 80 to aflibercept on a TAE schedule, 67 to monthly bevacizumab, and 67 to bevacizumab on a TAE schedule. Mean treatment group difference (the change in visual acuity letter score in the monthly group minus the change in the TAE group) from month 6 to month 12 was 1.88 (97.5%CI, -1.07 to 4.83; P = .15) for aflibercept and 1.98 (97.5%CI, -1.08 to 5.03; P = .15) for bevacizumab. In the aflibercept arm, the mean number of injections between months 6 and 11 was 5.8 in the monthly injection group (95%CI, 5.6 to 5.9) and 3.8 in the TAE group (95% CI, 3.5 to 4.1; P < .001); in the bevacizumab arm, the mean number of injections was 5.8 (95% CI, 5.6 to 5.9) in the monthly group and 4.5 in the TAE group (95%CI, 4.2 to 4.8; P < .001). CONCLUSIONS AND RELEVANCE One to 2 fewer injections of aflibercept or bevacizumab were given to the TAE groups than the monthly groups in months 6 to 12 for macular edema associated with central retinal or hemiretinal vein occlusion. Because of wide confidence intervals on the differences between the groups, caution is warranted before concluding that the regimens are associated with similar vision outcomes.

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U2 - 10.1001/jamaophthalmol.2017.6843

DO - 10.1001/jamaophthalmol.2017.6843

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VL - 136

SP - 337

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JO - JAMA Ophthalmology

JF - JAMA Ophthalmology

SN - 2168-6165

IS - 4

ER -