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Original Investigation
October 10, 2019

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

Author Affiliations
  • 1Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania
  • 2Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania
  • 3The Emmes Company, LLC, Rockville, Maryland
  • 4Doheny Eye Institute, UCLA (University of California, Los Angeles)
  • 5Fundus Photograph Reading Center, University of Wisconsin–Madison
  • 6Southern California Desert Retina, Palm Desert
JAMA Ophthalmol. Published online October 10, 2019. doi:10.1001/jamaophthalmol.2019.3947
Key Points

Question  From month 12 to 24 in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial, when treatment was at investigator discretion, what were outcomes among participants initially randomized to aflibercept or bevacizumab for treatment of macular edema due to central retinal or hemiretinal vein occlusion?

Findings  Among 236 participants in this secondary analysis of the SCORE2 randomized clinical trial, visual acuity letter score and optical coherence tomography–measured central subfield thickness improvement from baseline to month 12 subsequently worsened from month 12 to 24 in both groups, with no differences between treatment groups.

Meaning  Management of macular edema due to retinal vein occlusion likely warrants close monitoring for at least 2 years, although follow-up of only two-thirds of participants at month 24 limits confidence in these results.

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

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