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Brief Report
June 6, 2019

Patient-Reported Visual Function Outcomes After Anti–Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: Preplanned Secondary Analysis of a 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 Corporation, Rockville, Maryland
  • 4Doheny Eye Institute, University of California, Los Angeles
  • 5University of Wisconsin Fundus Photograph Reading Center, Madison
  • 6Retina Centers, PC, Tucson, Arizona
  • 7Texas Retina Associates, Dallas
JAMA Ophthalmol. 2019;137(8):932-938. doi:10.1001/jamaophthalmol.2019.1519
Key Points

Question  What was the effect of monthly treatment with aflibercept or bevacizumab on patient-reported visual function at month 6 in eyes with macular edema due to central retinal vein occlusion or hemiretinal vein occlusion?

Findings  In this preplanned secondary analysis of a randomized clinical trial of 346 patients, meaningful improvement from baseline to month 6 in patient-reported visual function occurred as assessed by the 25-item National Eye Institute Visual Function Questionnaire, with no differences at month 6 between eyes treated monthly with aflibercept or bevacizumab.

Meaning  The lack of difference between aflibercept and bevacizumab treatment for macular edema due to central retinal or hemiretinal vein occlusion in patient-reported visual function was consistent with the primary outcome findings at month 6, which showed that bevacizumab was noninferior to aflibercept for visual acuity.

Abstract

Importance  Anti–vascular endothelial growth factor (anti-VEGF) therapy is the standard-of-care first-line treatment for macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), and information is needed to assess the effect of anti-VEGF therapy on patient-reported visual function.

Objective  To investigate the effect of intravitreal aflibercept or bevacizumab on patient-reported visual function in patients with macular edema secondary to CRVO or HRVO.

Design, Setting, and Participants  This preplanned secondary analysis of the Study of Comparative Treatments for Retinal Vein Occlusion 2, a randomized clinical trial, included 346 participants from 66 private practice or academic centers in the United States. Participants had CRVO- or HRVO-associated macular edema and month 6 outcome information. Data were collected from September 17, 2014, through November 18, 2015, and analyzed from February 7, 2018, through February 26, 2019.

Interventions  Eyes were randomly assigned to receive an intravitreal injection of bevacizumab (1.25 mg) or aflibercept (2.0 mg) at baseline and every 4 weeks through month 5.

Main Outcomes and Measures  Difference between treatment arms at month 6 in the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ–25) composite and subscale scores.

Results  Among the 346 participants (56.1% men; mean [SD] age, 69 [12] years), significant improvements occurred from baseline to month 6 in the NEI VFQ-25 composite score in the aflibercept (mean [SE] change, 7.5 [0.9]; P < .001) and bevacizumab (mean [SE], 6.1 [0.9]; P < .001) arms and in 10 of 12 subscale scores after multiplicity adjustment. No differences were observed at month 6 in NEI VFQ-25 composite or subscale scores between participants randomized to aflibercept or bevacizumab treatment. Weak positive correlations were seen between the change in the study eyes’ visual acuity and the changes in the NEI VFQ-25 composite score (r = 0.22; P < .001) and the Distance Activities (r = 0.24; P < .001) and Driving (r = 0.19; P = .03) subscale scores.

Conclusions and Relevance  Significant improvement occurred from baseline to month 6 in patient-reported visual function as assessed by the NEI VFQ–25. The lack of difference in NEI VFQ–25 scores between study participants treated with monthly intravitreal aflibercept and bevacizumab for macular edema due to CRVO or HRVO at month 6 is consistent with the primary outcome finding that showed bevacizumab was noninferior to aflibercept with respect to visual acuity improvement from baseline to month 6.

Trial Registration  ClinicalTrials.gov identifier: NCT01969708

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