Baseline factors associated with 6-month visual acuity and retinal thickness outcomes in patients with macular edema secondary to central retinal vein occlusion or hemiretinal vein occlusion SCORE2 Study Report 4

Ingrid U. Scott, Paul C. Van Veldhuisen, Michael S. Ip, Barbara A. Blodi, Neal L. Oden, Jacqueline King, Andrew N. Antoszyk, Mark A. Peters, Michael Tolentino

Research output: Contribution to journalArticle

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Abstract

IMPORTANCE: Macular edema (ME) is the leading cause of decreased visual acuity (VA) associated with retinal vein occlusion (RVO). Identifying factors associated with better outcomes in RVO eyes treated with anti-vascular endothelial growth factor (VEGF) therapy may provide information useful in counseling patients. OBJECTIVE: To investigate baseline characteristics associated with 6-month VA and central subfield thickness (CST) outcomes in participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2). DESIGN, SETTING, AND PARTICIPANTS: A total of 362 patients with central RVO or hemi-RVO were enrolled between September 17, 2014, and November 18,2015, and randomized 1:1 in a masked fashion to receive bevacizumab or aflibercept. At month 6, 348 participants (96%) had VA outcomes measured and 335 participants (93%) had spectral domain optical coherence tomography outcomes measured. The current data analysis was conducted from February 27, 2017, to April 7, 2017. 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, with the primary outcome measured at 6 months. MAIN OUTCOMES AND MEASURES; Change from baseline in VA letter score (VALS), VALS gain of 15 or more, change from baseline in CST, CST less than 300 μm, and resolution of ME. Baseline factors associated with 6-month outcome at the 0.05 level in univariate regressions were included in multivariate regressions, with those significant after multiplicity control by the Hochberg method reported. RESULTS: The mean (SD) age of patients was 69 (12) years, and 43% were women. Younger patient age (odds ratio [OR], 0.95 per year of age; 95% CI, 0.93-0.98; P =.007) and lower baseline VALS (OR, 0.96 per letter; 95% CI, 0.94-0.98; P <.001) were associated with a 6-month VALS gain of 15 or greater. Compared with bevacizumab, aflibercept treatment was associated with a higher odds of ME resolution (OR, 3.59; 95% CI, 2.22-5.80; P <.001) and CST less than 300 μm (OR, 5.30; 95% CI, 2.40-11.67; P =.001), but not with a better VA outcome. Macular edema was less likely to resolve in eyes that received anti-VEGF treatment prior to study participation (OR, 0.33; 95% CI, 0.17-0.64; P =.03). CONCLUSIONS AND RELEVANCE: In eyes treated with bevacizumab or aflibercept, younger age and worse baseline VALS were associated with better 6-month VA outcomes. Aflibercept treatment was associated with more favorable spectral domain optical coherence tomography outcomes but not VA outcomes. These findings may be useful in assessing expected response at month 6 after monthly injection of anti-VEGF agents for treating ME due to CRVO and HRVO.

Original languageEnglish (US)
Pages (from-to)639-649
Number of pages11
JournalJAMA Ophthalmology
Volume135
Issue number6
DOIs
StatePublished - Jun 2017

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Retinal Vein
Retinal Vein Occlusion
Macular Edema
Visual Acuity
Veins
Odds Ratio
Vascular Endothelial Growth Factor A
Optical Coherence Tomography
Therapeutics
Intravitreal Injections
Counseling
aflibercept
Injections
Bevacizumab

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

Scott, Ingrid U. ; Van Veldhuisen, Paul C. ; Ip, Michael S. ; Blodi, Barbara A. ; Oden, Neal L. ; King, Jacqueline ; Antoszyk, Andrew N. ; Peters, Mark A. ; Tolentino, Michael. / Baseline factors associated with 6-month visual acuity and retinal thickness outcomes in patients with macular edema secondary to central retinal vein occlusion or hemiretinal vein occlusion SCORE2 Study Report 4. In: JAMA Ophthalmology. 2017 ; Vol. 135, No. 6. pp. 639-649.
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abstract = "IMPORTANCE: Macular edema (ME) is the leading cause of decreased visual acuity (VA) associated with retinal vein occlusion (RVO). Identifying factors associated with better outcomes in RVO eyes treated with anti-vascular endothelial growth factor (VEGF) therapy may provide information useful in counseling patients. OBJECTIVE: To investigate baseline characteristics associated with 6-month VA and central subfield thickness (CST) outcomes in participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2). DESIGN, SETTING, AND PARTICIPANTS: A total of 362 patients with central RVO or hemi-RVO were enrolled between September 17, 2014, and November 18,2015, and randomized 1:1 in a masked fashion to receive bevacizumab or aflibercept. At month 6, 348 participants (96{\%}) had VA outcomes measured and 335 participants (93{\%}) had spectral domain optical coherence tomography outcomes measured. The current data analysis was conducted from February 27, 2017, to April 7, 2017. 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, with the primary outcome measured at 6 months. MAIN OUTCOMES AND MEASURES; Change from baseline in VA letter score (VALS), VALS gain of 15 or more, change from baseline in CST, CST less than 300 μm, and resolution of ME. Baseline factors associated with 6-month outcome at the 0.05 level in univariate regressions were included in multivariate regressions, with those significant after multiplicity control by the Hochberg method reported. RESULTS: The mean (SD) age of patients was 69 (12) years, and 43{\%} were women. Younger patient age (odds ratio [OR], 0.95 per year of age; 95{\%} CI, 0.93-0.98; P =.007) and lower baseline VALS (OR, 0.96 per letter; 95{\%} CI, 0.94-0.98; P <.001) were associated with a 6-month VALS gain of 15 or greater. Compared with bevacizumab, aflibercept treatment was associated with a higher odds of ME resolution (OR, 3.59; 95{\%} CI, 2.22-5.80; P <.001) and CST less than 300 μm (OR, 5.30; 95{\%} CI, 2.40-11.67; P =.001), but not with a better VA outcome. Macular edema was less likely to resolve in eyes that received anti-VEGF treatment prior to study participation (OR, 0.33; 95{\%} CI, 0.17-0.64; P =.03). CONCLUSIONS AND RELEVANCE: In eyes treated with bevacizumab or aflibercept, younger age and worse baseline VALS were associated with better 6-month VA outcomes. Aflibercept treatment was associated with more favorable spectral domain optical coherence tomography outcomes but not VA outcomes. These findings may be useful in assessing expected response at month 6 after monthly injection of anti-VEGF agents for treating ME due to CRVO and HRVO.",
author = "Scott, {Ingrid U.} and {Van Veldhuisen}, {Paul C.} and Ip, {Michael S.} and Blodi, {Barbara A.} and Oden, {Neal L.} and Jacqueline King and Antoszyk, {Andrew N.} and Peters, {Mark A.} and Michael Tolentino",
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Baseline factors associated with 6-month visual acuity and retinal thickness outcomes in patients with macular edema secondary to central retinal vein occlusion or hemiretinal vein occlusion SCORE2 Study Report 4. / Scott, Ingrid U.; Van Veldhuisen, Paul C.; Ip, Michael S.; Blodi, Barbara A.; Oden, Neal L.; King, Jacqueline; Antoszyk, Andrew N.; Peters, Mark A.; Tolentino, Michael.

In: JAMA Ophthalmology, Vol. 135, No. 6, 06.2017, p. 639-649.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Baseline factors associated with 6-month visual acuity and retinal thickness outcomes in patients with macular edema secondary to central retinal vein occlusion or hemiretinal vein occlusion SCORE2 Study Report 4

AU - Scott, Ingrid U.

AU - Van Veldhuisen, Paul C.

AU - Ip, Michael S.

AU - Blodi, Barbara A.

AU - Oden, Neal L.

AU - King, Jacqueline

AU - Antoszyk, Andrew N.

AU - Peters, Mark A.

AU - Tolentino, Michael

PY - 2017/6

Y1 - 2017/6

N2 - IMPORTANCE: Macular edema (ME) is the leading cause of decreased visual acuity (VA) associated with retinal vein occlusion (RVO). Identifying factors associated with better outcomes in RVO eyes treated with anti-vascular endothelial growth factor (VEGF) therapy may provide information useful in counseling patients. OBJECTIVE: To investigate baseline characteristics associated with 6-month VA and central subfield thickness (CST) outcomes in participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2). DESIGN, SETTING, AND PARTICIPANTS: A total of 362 patients with central RVO or hemi-RVO were enrolled between September 17, 2014, and November 18,2015, and randomized 1:1 in a masked fashion to receive bevacizumab or aflibercept. At month 6, 348 participants (96%) had VA outcomes measured and 335 participants (93%) had spectral domain optical coherence tomography outcomes measured. The current data analysis was conducted from February 27, 2017, to April 7, 2017. 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, with the primary outcome measured at 6 months. MAIN OUTCOMES AND MEASURES; Change from baseline in VA letter score (VALS), VALS gain of 15 or more, change from baseline in CST, CST less than 300 μm, and resolution of ME. Baseline factors associated with 6-month outcome at the 0.05 level in univariate regressions were included in multivariate regressions, with those significant after multiplicity control by the Hochberg method reported. RESULTS: The mean (SD) age of patients was 69 (12) years, and 43% were women. Younger patient age (odds ratio [OR], 0.95 per year of age; 95% CI, 0.93-0.98; P =.007) and lower baseline VALS (OR, 0.96 per letter; 95% CI, 0.94-0.98; P <.001) were associated with a 6-month VALS gain of 15 or greater. Compared with bevacizumab, aflibercept treatment was associated with a higher odds of ME resolution (OR, 3.59; 95% CI, 2.22-5.80; P <.001) and CST less than 300 μm (OR, 5.30; 95% CI, 2.40-11.67; P =.001), but not with a better VA outcome. Macular edema was less likely to resolve in eyes that received anti-VEGF treatment prior to study participation (OR, 0.33; 95% CI, 0.17-0.64; P =.03). CONCLUSIONS AND RELEVANCE: In eyes treated with bevacizumab or aflibercept, younger age and worse baseline VALS were associated with better 6-month VA outcomes. Aflibercept treatment was associated with more favorable spectral domain optical coherence tomography outcomes but not VA outcomes. These findings may be useful in assessing expected response at month 6 after monthly injection of anti-VEGF agents for treating ME due to CRVO and HRVO.

AB - IMPORTANCE: Macular edema (ME) is the leading cause of decreased visual acuity (VA) associated with retinal vein occlusion (RVO). Identifying factors associated with better outcomes in RVO eyes treated with anti-vascular endothelial growth factor (VEGF) therapy may provide information useful in counseling patients. OBJECTIVE: To investigate baseline characteristics associated with 6-month VA and central subfield thickness (CST) outcomes in participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2). DESIGN, SETTING, AND PARTICIPANTS: A total of 362 patients with central RVO or hemi-RVO were enrolled between September 17, 2014, and November 18,2015, and randomized 1:1 in a masked fashion to receive bevacizumab or aflibercept. At month 6, 348 participants (96%) had VA outcomes measured and 335 participants (93%) had spectral domain optical coherence tomography outcomes measured. The current data analysis was conducted from February 27, 2017, to April 7, 2017. 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, with the primary outcome measured at 6 months. MAIN OUTCOMES AND MEASURES; Change from baseline in VA letter score (VALS), VALS gain of 15 or more, change from baseline in CST, CST less than 300 μm, and resolution of ME. Baseline factors associated with 6-month outcome at the 0.05 level in univariate regressions were included in multivariate regressions, with those significant after multiplicity control by the Hochberg method reported. RESULTS: The mean (SD) age of patients was 69 (12) years, and 43% were women. Younger patient age (odds ratio [OR], 0.95 per year of age; 95% CI, 0.93-0.98; P =.007) and lower baseline VALS (OR, 0.96 per letter; 95% CI, 0.94-0.98; P <.001) were associated with a 6-month VALS gain of 15 or greater. Compared with bevacizumab, aflibercept treatment was associated with a higher odds of ME resolution (OR, 3.59; 95% CI, 2.22-5.80; P <.001) and CST less than 300 μm (OR, 5.30; 95% CI, 2.40-11.67; P =.001), but not with a better VA outcome. Macular edema was less likely to resolve in eyes that received anti-VEGF treatment prior to study participation (OR, 0.33; 95% CI, 0.17-0.64; P =.03). CONCLUSIONS AND RELEVANCE: In eyes treated with bevacizumab or aflibercept, younger age and worse baseline VALS were associated with better 6-month VA outcomes. Aflibercept treatment was associated with more favorable spectral domain optical coherence tomography outcomes but not VA outcomes. These findings may be useful in assessing expected response at month 6 after monthly injection of anti-VEGF agents for treating ME due to CRVO and HRVO.

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