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
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  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.