Month 24 Outcomes after Treatment Initiation with Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: SCORE2 Report 10: A Secondary Analysis of the SCORE2 Randomized Clinical Trial

Ingrid U. Scott, Neal L. Oden, Paul C. VanVeldhuisen, Michael S. Ip, Barbara A. Blodi, Clement K. Chan

Research output: Contribution to journalArticle

Abstract

Importance: Two-year outcomes are reported comparing eyes originally assigned to aflibercept or bevacizumab to assess the need for continued anti-vascular endothelial growth factor (VEGF) therapy for macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) from participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial. Objective: To investigate outcomes 1 year after cessation of the SCORE2 treatment schedule. Design, Setting, and Participants: In this secondary analysis of the SCORE2 randomized clinical trial, follow-up included 117 participants originally randomized to aflibercept and 119 participants originally randomized to bevacizumab between September 17, 2014, and November 18, 2015. Data for the analyses were frozen on September 13, 2018. Interventions: SCORE2 participants completed the treatment protocol at month 12, were subsequently treated at investigator discretion, and underwent assessment at month 24. Main Outcomes and Measures: Visual acuity letter score (VALS) and central subfield thickness (CST) on spectral-domain optical coherence tomography. Results: Among 362 participants randomized to aflibercept or bevacizumab, 65.2% (236 of 362) completed a protocol visit at month 24 (mean [SD] age, 68.5 (12.0) years; 53.8% male). The mean (SD) VALS improved from baseline to 12 months by 21.6 (14.5) in the aflibercept group compared with 21.9 (16.6) in the bevacizumab group (difference, -0.3; 99% CI, -5.6 to 4.9), then worsened from those values by a mean (SD) VALS of 7.6 (17.5) in the aflibercept group and 7.5 (14.5) in the bevacizumab group (difference, -0.1; 99% CI, -5.6 to 5.3) at month 24. The mean (SD) CST improved from baseline to 12 months by 394 (231) μm in the aflibercept group compared with 420 (274) μm in the bevacizumab group (difference, 26 μm; 99% CI, -62 to 114 μm), then worsened from those values by a mean (SD) of 58 (192) μm in the aflibercept group compared with 48 (186) μm in the bevacizumab group (difference, 10 μm; 99% CI, -58 to 78 μm) at month 24. Conclusions and Relevance: No differences in VALS or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab. Caution in interpretation is needed because of loss to follow-up. In both groups, VALS and CST improved through month 12 and then worsened somewhat during the second year, when treatment was at investigator discretion. This analysis suggests that CRVO and HRVO warrant close monitoring and treatment as needed over at least 2 years to optimize outcomes in eyes treated with anti-VEGF therapy. Trial Registration: ClinicalTrials.gov identifier: NCT01969708.

Original languageEnglish (US)
Pages (from-to)1389-1398
Number of pages10
JournalJAMA Ophthalmology
Volume137
Issue number12
DOIs
StatePublished - Dec 2019

Fingerprint

Macular Edema
Vascular Endothelial Growth Factor A
Veins
Randomized Controlled Trials
Visual Acuity
Retinal Vein Occlusion
Retinal Vein
Therapeutics
Research Personnel
Withholding Treatment
Bevacizumab
aflibercept
Optical Coherence Tomography
Clinical Protocols
Appointments and Schedules
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

@article{6110ef3579b74dba956551aa0a995527,
title = "Month 24 Outcomes after Treatment Initiation with Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: SCORE2 Report 10: A Secondary Analysis of the SCORE2 Randomized Clinical Trial",
abstract = "Importance: Two-year outcomes are reported comparing eyes originally assigned to aflibercept or bevacizumab to assess the need for continued anti-vascular endothelial growth factor (VEGF) therapy for macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) from participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial. Objective: To investigate outcomes 1 year after cessation of the SCORE2 treatment schedule. Design, Setting, and Participants: In this secondary analysis of the SCORE2 randomized clinical trial, follow-up included 117 participants originally randomized to aflibercept and 119 participants originally randomized to bevacizumab between September 17, 2014, and November 18, 2015. Data for the analyses were frozen on September 13, 2018. Interventions: SCORE2 participants completed the treatment protocol at month 12, were subsequently treated at investigator discretion, and underwent assessment at month 24. Main Outcomes and Measures: Visual acuity letter score (VALS) and central subfield thickness (CST) on spectral-domain optical coherence tomography. Results: Among 362 participants randomized to aflibercept or bevacizumab, 65.2{\%} (236 of 362) completed a protocol visit at month 24 (mean [SD] age, 68.5 (12.0) years; 53.8{\%} male). The mean (SD) VALS improved from baseline to 12 months by 21.6 (14.5) in the aflibercept group compared with 21.9 (16.6) in the bevacizumab group (difference, -0.3; 99{\%} CI, -5.6 to 4.9), then worsened from those values by a mean (SD) VALS of 7.6 (17.5) in the aflibercept group and 7.5 (14.5) in the bevacizumab group (difference, -0.1; 99{\%} CI, -5.6 to 5.3) at month 24. The mean (SD) CST improved from baseline to 12 months by 394 (231) μm in the aflibercept group compared with 420 (274) μm in the bevacizumab group (difference, 26 μm; 99{\%} CI, -62 to 114 μm), then worsened from those values by a mean (SD) of 58 (192) μm in the aflibercept group compared with 48 (186) μm in the bevacizumab group (difference, 10 μm; 99{\%} CI, -58 to 78 μm) at month 24. Conclusions and Relevance: No differences in VALS or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab. Caution in interpretation is needed because of loss to follow-up. In both groups, VALS and CST improved through month 12 and then worsened somewhat during the second year, when treatment was at investigator discretion. This analysis suggests that CRVO and HRVO warrant close monitoring and treatment as needed over at least 2 years to optimize outcomes in eyes treated with anti-VEGF therapy. Trial Registration: ClinicalTrials.gov identifier: NCT01969708.",
author = "Scott, {Ingrid U.} and Oden, {Neal L.} and VanVeldhuisen, {Paul C.} and Ip, {Michael S.} and Blodi, {Barbara A.} and Chan, {Clement K.}",
year = "2019",
month = "12",
doi = "10.1001/jamaophthalmol.2019.3947",
language = "English (US)",
volume = "137",
pages = "1389--1398",
journal = "JAMA Ophthalmology",
issn = "2168-6165",
publisher = "American Medical Association",
number = "12",

}

Month 24 Outcomes after Treatment Initiation with Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion : SCORE2 Report 10: A Secondary Analysis of the SCORE2 Randomized Clinical Trial. / Scott, Ingrid U.; Oden, Neal L.; VanVeldhuisen, Paul C.; Ip, Michael S.; Blodi, Barbara A.; Chan, Clement K.

In: JAMA Ophthalmology, Vol. 137, No. 12, 12.2019, p. 1389-1398.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Month 24 Outcomes after Treatment Initiation with Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion

T2 - SCORE2 Report 10: A Secondary Analysis of the SCORE2 Randomized Clinical Trial

AU - Scott, Ingrid U.

AU - Oden, Neal L.

AU - VanVeldhuisen, Paul C.

AU - Ip, Michael S.

AU - Blodi, Barbara A.

AU - Chan, Clement K.

PY - 2019/12

Y1 - 2019/12

N2 - Importance: Two-year outcomes are reported comparing eyes originally assigned to aflibercept or bevacizumab to assess the need for continued anti-vascular endothelial growth factor (VEGF) therapy for macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) from participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial. Objective: To investigate outcomes 1 year after cessation of the SCORE2 treatment schedule. Design, Setting, and Participants: In this secondary analysis of the SCORE2 randomized clinical trial, follow-up included 117 participants originally randomized to aflibercept and 119 participants originally randomized to bevacizumab between September 17, 2014, and November 18, 2015. Data for the analyses were frozen on September 13, 2018. Interventions: SCORE2 participants completed the treatment protocol at month 12, were subsequently treated at investigator discretion, and underwent assessment at month 24. Main Outcomes and Measures: Visual acuity letter score (VALS) and central subfield thickness (CST) on spectral-domain optical coherence tomography. Results: Among 362 participants randomized to aflibercept or bevacizumab, 65.2% (236 of 362) completed a protocol visit at month 24 (mean [SD] age, 68.5 (12.0) years; 53.8% male). The mean (SD) VALS improved from baseline to 12 months by 21.6 (14.5) in the aflibercept group compared with 21.9 (16.6) in the bevacizumab group (difference, -0.3; 99% CI, -5.6 to 4.9), then worsened from those values by a mean (SD) VALS of 7.6 (17.5) in the aflibercept group and 7.5 (14.5) in the bevacizumab group (difference, -0.1; 99% CI, -5.6 to 5.3) at month 24. The mean (SD) CST improved from baseline to 12 months by 394 (231) μm in the aflibercept group compared with 420 (274) μm in the bevacizumab group (difference, 26 μm; 99% CI, -62 to 114 μm), then worsened from those values by a mean (SD) of 58 (192) μm in the aflibercept group compared with 48 (186) μm in the bevacizumab group (difference, 10 μm; 99% CI, -58 to 78 μm) at month 24. Conclusions and Relevance: No differences in VALS or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab. Caution in interpretation is needed because of loss to follow-up. In both groups, VALS and CST improved through month 12 and then worsened somewhat during the second year, when treatment was at investigator discretion. This analysis suggests that CRVO and HRVO warrant close monitoring and treatment as needed over at least 2 years to optimize outcomes in eyes treated with anti-VEGF therapy. Trial Registration: ClinicalTrials.gov identifier: NCT01969708.

AB - Importance: Two-year outcomes are reported comparing eyes originally assigned to aflibercept or bevacizumab to assess the need for continued anti-vascular endothelial growth factor (VEGF) therapy for macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) from participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial. Objective: To investigate outcomes 1 year after cessation of the SCORE2 treatment schedule. Design, Setting, and Participants: In this secondary analysis of the SCORE2 randomized clinical trial, follow-up included 117 participants originally randomized to aflibercept and 119 participants originally randomized to bevacizumab between September 17, 2014, and November 18, 2015. Data for the analyses were frozen on September 13, 2018. Interventions: SCORE2 participants completed the treatment protocol at month 12, were subsequently treated at investigator discretion, and underwent assessment at month 24. Main Outcomes and Measures: Visual acuity letter score (VALS) and central subfield thickness (CST) on spectral-domain optical coherence tomography. Results: Among 362 participants randomized to aflibercept or bevacizumab, 65.2% (236 of 362) completed a protocol visit at month 24 (mean [SD] age, 68.5 (12.0) years; 53.8% male). The mean (SD) VALS improved from baseline to 12 months by 21.6 (14.5) in the aflibercept group compared with 21.9 (16.6) in the bevacizumab group (difference, -0.3; 99% CI, -5.6 to 4.9), then worsened from those values by a mean (SD) VALS of 7.6 (17.5) in the aflibercept group and 7.5 (14.5) in the bevacizumab group (difference, -0.1; 99% CI, -5.6 to 5.3) at month 24. The mean (SD) CST improved from baseline to 12 months by 394 (231) μm in the aflibercept group compared with 420 (274) μm in the bevacizumab group (difference, 26 μm; 99% CI, -62 to 114 μm), then worsened from those values by a mean (SD) of 58 (192) μm in the aflibercept group compared with 48 (186) μm in the bevacizumab group (difference, 10 μm; 99% CI, -58 to 78 μm) at month 24. Conclusions and Relevance: No differences in VALS or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab. Caution in interpretation is needed because of loss to follow-up. In both groups, VALS and CST improved through month 12 and then worsened somewhat during the second year, when treatment was at investigator discretion. This analysis suggests that CRVO and HRVO warrant close monitoring and treatment as needed over at least 2 years to optimize outcomes in eyes treated with anti-VEGF therapy. Trial Registration: ClinicalTrials.gov identifier: NCT01969708.

UR - http://www.scopus.com/inward/record.url?scp=85073614008&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85073614008&partnerID=8YFLogxK

U2 - 10.1001/jamaophthalmol.2019.3947

DO - 10.1001/jamaophthalmol.2019.3947

M3 - Article

C2 - 31600368

AN - SCOPUS:85073614008

VL - 137

SP - 1389

EP - 1398

JO - JAMA Ophthalmology

JF - JAMA Ophthalmology

SN - 2168-6165

IS - 12

ER -