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

Ingrid Scott, Paul C. Vanveldhuisen, Franca Barton, Neal L. Oden, Michael S. Ip, Barbara A. Blodi, Martin Worrall, Gary E. Fish

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)932-938
Number of pages7
JournalJAMA Ophthalmology
Volume137
Issue number8
DOIs
StatePublished - Aug 1 2019

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Macular Edema
Retinal Vein Occlusion
Vascular Endothelial Growth Factor A
Retinal Vein
Veins
Randomized Controlled Trials
Visual Acuity
Arm
Therapeutics
National Eye Institute (U.S.)
Social Adjustment
Intravitreal Injections
Private Practice
Standard of Care
Bevacizumab
aflibercept
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

Scott, Ingrid ; Vanveldhuisen, Paul C. ; Barton, Franca ; Oden, Neal L. ; Ip, Michael S. ; Blodi, Barbara A. ; Worrall, Martin ; Fish, Gary E. / 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. In: JAMA Ophthalmology. 2019 ; Vol. 137, No. 8. pp. 932-938.
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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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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. / Scott, Ingrid; Vanveldhuisen, Paul C.; Barton, Franca; Oden, Neal L.; Ip, Michael S.; Blodi, Barbara A.; Worrall, Martin; Fish, Gary E.

In: JAMA Ophthalmology, Vol. 137, No. 8, 01.08.2019, p. 932-938.

Research output: Contribution to journalArticle

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T2 - Preplanned Secondary Analysis of a Randomized Clinical Trial

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AU - Fish, Gary E.

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N2 - 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.

AB - 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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