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.

2019 Jun 06

Journal Article

Authors:

Secondary:
JAMA Ophthalmol

PMID:
31169862

DOI:
10.1001/jamaophthalmol.2019.1519

Abstract:
<p>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 &lt; .001) and bevacizumab (mean [SE], 6.1 [0.9]; P &lt; .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&#039; visual acuity and the changes in the NEI VFQ-25 composite score (r = 0.22; P &lt; .001) and the Distance Activities (r = 0.24; P &lt; .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.</p>