SCORE2 Report 2: Study Design and Baseline Characteristics

Ingrid U. Scott, Paul C. VanVeldhuisen, Michael S. Ip, Barbara A. Blodi, Neal L. Oden, Maria Figueroa, Pravin U. Dugel

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Purpose To describe the design and baseline characteristics of participants in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) and to compare with cohorts from other retinal vein occlusion trials. Design Phase III prospective, multicenter, randomized clinical trial designed to assess whether intravitreal bevacizumab is noninferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO). Participants Total of 362 participants: 307 with CRVO and 55 with HRVO. Methods Demographic and study eye characteristics are summarized and compared between CRVO and HRVO study participants. Main Outcome Measures Baseline ophthalmic characteristics, including visual acuity and retinal thickness, and medical history characteristics, including hypertension, diabetes mellitus, and coronary artery disease. Results The mean age of participants was 69 years, 76% of participants were white, and 90% were non-Hispanic. There was a racial disparity with respect to disease type, with 38% of HRVO patients being black compared with 11% of CRVO patients (P value adjusted for multiple testing = 0.0001). This is similar to findings from the previous SCORE Study. Comorbidities included hypertension (77%), diabetes mellitus (31%), and coronary artery disease (15%). At baseline, mean visual acuity letter score was 50 (20/100) (range, 19–73 [20/400 to 20/40]), mean optical coherence tomography (OCT)–measured central subfield thickness was 678 μm (range, 300–1203 μm), and mean number of months from diagnosis of macular edema to randomization was 6 (range, 0–104 months). One hundred twenty (33%) SCORE2 participants had been treated previously with anti–vascular endothelial growth factor (anti-VEGF) therapy, with these participants having baseline visual acuity letter score and OCT-measured central subfield thickness similar to those without prior anti-VEGF treatment, but longer mean duration of macular edema before randomization (18 months vs. 1 month for those without prior anti-VEGF treatment; P < 0.0001). Conclusions The SCORE2 cohort is a heterogeneous population, including both CRVO and HRVO eyes and both treatment-naïve eyes and eyes treated previously with anti-VEGF, which will allow study results to have broad applicability to CRVO and HRVO patients receiving treatment for macular edema. Similarities of the baseline characteristics of the SCORE2 population to other CRVO trial cohorts will allow meaningful comparisons of outcome results across trials.

Original languageEnglish (US)
Pages (from-to)245-256
Number of pages12
JournalOphthalmology
Volume124
Issue number2
DOIs
StatePublished - Feb 1 2017

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Retinal Vein Occlusion
Retinal Vein
Endothelial Growth Factors
Veins
Macular Edema
Visual Acuity
Optical Coherence Tomography
Random Allocation
Therapeutics
Coronary Artery Disease
Diabetes Mellitus
Hypertension
Population Characteristics
Comorbidity
Randomized Controlled Trials
Demography
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

Scott, I. U., VanVeldhuisen, P. C., Ip, M. S., Blodi, B. A., Oden, N. L., Figueroa, M., & Dugel, P. U. (2017). SCORE2 Report 2: Study Design and Baseline Characteristics. Ophthalmology, 124(2), 245-256. https://doi.org/10.1016/j.ophtha.2016.09.038
Scott, Ingrid U. ; VanVeldhuisen, Paul C. ; Ip, Michael S. ; Blodi, Barbara A. ; Oden, Neal L. ; Figueroa, Maria ; Dugel, Pravin U. / SCORE2 Report 2 : Study Design and Baseline Characteristics. In: Ophthalmology. 2017 ; Vol. 124, No. 2. pp. 245-256.
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abstract = "Purpose To describe the design and baseline characteristics of participants in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) and to compare with cohorts from other retinal vein occlusion trials. Design Phase III prospective, multicenter, randomized clinical trial designed to assess whether intravitreal bevacizumab is noninferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO). Participants Total of 362 participants: 307 with CRVO and 55 with HRVO. Methods Demographic and study eye characteristics are summarized and compared between CRVO and HRVO study participants. Main Outcome Measures Baseline ophthalmic characteristics, including visual acuity and retinal thickness, and medical history characteristics, including hypertension, diabetes mellitus, and coronary artery disease. Results The mean age of participants was 69 years, 76{\%} of participants were white, and 90{\%} were non-Hispanic. There was a racial disparity with respect to disease type, with 38{\%} of HRVO patients being black compared with 11{\%} of CRVO patients (P value adjusted for multiple testing = 0.0001). This is similar to findings from the previous SCORE Study. Comorbidities included hypertension (77{\%}), diabetes mellitus (31{\%}), and coronary artery disease (15{\%}). At baseline, mean visual acuity letter score was 50 (20/100) (range, 19–73 [20/400 to 20/40]), mean optical coherence tomography (OCT)–measured central subfield thickness was 678 μm (range, 300–1203 μm), and mean number of months from diagnosis of macular edema to randomization was 6 (range, 0–104 months). One hundred twenty (33{\%}) SCORE2 participants had been treated previously with anti–vascular endothelial growth factor (anti-VEGF) therapy, with these participants having baseline visual acuity letter score and OCT-measured central subfield thickness similar to those without prior anti-VEGF treatment, but longer mean duration of macular edema before randomization (18 months vs. 1 month for those without prior anti-VEGF treatment; P < 0.0001). Conclusions The SCORE2 cohort is a heterogeneous population, including both CRVO and HRVO eyes and both treatment-na{\"i}ve eyes and eyes treated previously with anti-VEGF, which will allow study results to have broad applicability to CRVO and HRVO patients receiving treatment for macular edema. Similarities of the baseline characteristics of the SCORE2 population to other CRVO trial cohorts will allow meaningful comparisons of outcome results across trials.",
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Scott, IU, VanVeldhuisen, PC, Ip, MS, Blodi, BA, Oden, NL, Figueroa, M & Dugel, PU 2017, 'SCORE2 Report 2: Study Design and Baseline Characteristics', Ophthalmology, vol. 124, no. 2, pp. 245-256. https://doi.org/10.1016/j.ophtha.2016.09.038

SCORE2 Report 2 : Study Design and Baseline Characteristics. / Scott, Ingrid U.; VanVeldhuisen, Paul C.; Ip, Michael S.; Blodi, Barbara A.; Oden, Neal L.; Figueroa, Maria; Dugel, Pravin U.

In: Ophthalmology, Vol. 124, No. 2, 01.02.2017, p. 245-256.

Research output: Contribution to journalArticle

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T2 - Study Design and Baseline Characteristics

AU - Scott, Ingrid U.

AU - VanVeldhuisen, Paul C.

AU - Ip, Michael S.

AU - Blodi, Barbara A.

AU - Oden, Neal L.

AU - Figueroa, Maria

AU - Dugel, Pravin U.

PY - 2017/2/1

Y1 - 2017/2/1

N2 - Purpose To describe the design and baseline characteristics of participants in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) and to compare with cohorts from other retinal vein occlusion trials. Design Phase III prospective, multicenter, randomized clinical trial designed to assess whether intravitreal bevacizumab is noninferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO). Participants Total of 362 participants: 307 with CRVO and 55 with HRVO. Methods Demographic and study eye characteristics are summarized and compared between CRVO and HRVO study participants. Main Outcome Measures Baseline ophthalmic characteristics, including visual acuity and retinal thickness, and medical history characteristics, including hypertension, diabetes mellitus, and coronary artery disease. Results The mean age of participants was 69 years, 76% of participants were white, and 90% were non-Hispanic. There was a racial disparity with respect to disease type, with 38% of HRVO patients being black compared with 11% of CRVO patients (P value adjusted for multiple testing = 0.0001). This is similar to findings from the previous SCORE Study. Comorbidities included hypertension (77%), diabetes mellitus (31%), and coronary artery disease (15%). At baseline, mean visual acuity letter score was 50 (20/100) (range, 19–73 [20/400 to 20/40]), mean optical coherence tomography (OCT)–measured central subfield thickness was 678 μm (range, 300–1203 μm), and mean number of months from diagnosis of macular edema to randomization was 6 (range, 0–104 months). One hundred twenty (33%) SCORE2 participants had been treated previously with anti–vascular endothelial growth factor (anti-VEGF) therapy, with these participants having baseline visual acuity letter score and OCT-measured central subfield thickness similar to those without prior anti-VEGF treatment, but longer mean duration of macular edema before randomization (18 months vs. 1 month for those without prior anti-VEGF treatment; P < 0.0001). Conclusions The SCORE2 cohort is a heterogeneous population, including both CRVO and HRVO eyes and both treatment-naïve eyes and eyes treated previously with anti-VEGF, which will allow study results to have broad applicability to CRVO and HRVO patients receiving treatment for macular edema. Similarities of the baseline characteristics of the SCORE2 population to other CRVO trial cohorts will allow meaningful comparisons of outcome results across trials.

AB - Purpose To describe the design and baseline characteristics of participants in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) and to compare with cohorts from other retinal vein occlusion trials. Design Phase III prospective, multicenter, randomized clinical trial designed to assess whether intravitreal bevacizumab is noninferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO). Participants Total of 362 participants: 307 with CRVO and 55 with HRVO. Methods Demographic and study eye characteristics are summarized and compared between CRVO and HRVO study participants. Main Outcome Measures Baseline ophthalmic characteristics, including visual acuity and retinal thickness, and medical history characteristics, including hypertension, diabetes mellitus, and coronary artery disease. Results The mean age of participants was 69 years, 76% of participants were white, and 90% were non-Hispanic. There was a racial disparity with respect to disease type, with 38% of HRVO patients being black compared with 11% of CRVO patients (P value adjusted for multiple testing = 0.0001). This is similar to findings from the previous SCORE Study. Comorbidities included hypertension (77%), diabetes mellitus (31%), and coronary artery disease (15%). At baseline, mean visual acuity letter score was 50 (20/100) (range, 19–73 [20/400 to 20/40]), mean optical coherence tomography (OCT)–measured central subfield thickness was 678 μm (range, 300–1203 μm), and mean number of months from diagnosis of macular edema to randomization was 6 (range, 0–104 months). One hundred twenty (33%) SCORE2 participants had been treated previously with anti–vascular endothelial growth factor (anti-VEGF) therapy, with these participants having baseline visual acuity letter score and OCT-measured central subfield thickness similar to those without prior anti-VEGF treatment, but longer mean duration of macular edema before randomization (18 months vs. 1 month for those without prior anti-VEGF treatment; P < 0.0001). Conclusions The SCORE2 cohort is a heterogeneous population, including both CRVO and HRVO eyes and both treatment-naïve eyes and eyes treated previously with anti-VEGF, which will allow study results to have broad applicability to CRVO and HRVO patients receiving treatment for macular edema. Similarities of the baseline characteristics of the SCORE2 population to other CRVO trial cohorts will allow meaningful comparisons of outcome results across trials.

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Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Figueroa M et al. SCORE2 Report 2: Study Design and Baseline Characteristics. Ophthalmology. 2017 Feb 1;124(2):245-256. https://doi.org/10.1016/j.ophtha.2016.09.038