SCORE2 Report 2

Abstract

Objectives 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 non-inferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO). Participants 362 participants, including 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 to 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 (VALS) was 50 (20/100) (range: 19–73; 20/400-20/40), mean optical coherence tomography-measured central subfield thickness (OCT-CST) was 678 microns (range: 300–1203), and mean number of months from diagnosis of macular edema to randomization was 6 (range: 0–104). One hundred twenty (33%) SCORE2 participants had been treated previously with anti-VEGF therapy, with these participants having baseline VALS and OCT-CST similar to those without prior anti-VEGF treatment, but longer mean duration of macular edema before randomization (18 months versus 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-naive 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.

SCORE2 Report 5: Vision-Related Function in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

“…Baseline characteristics of the SCORE2 study population have been described in detail, 7 and selected characteristics are presented in Table 1. The mean age of SCORE2 participants was 69 years, with 43% women, and 76% white.…”

“…The SCORE2 design and methods have been described in detail 7 and are summarized here. The study adhered to the tenets of the Declaration of Helsinki 12 and is registered on http://www.clinicaltrials.gov (identifier: NCT01969708).…”

“…4–6 The Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) is a phase 3 randomized controlled clinical trial conducted to investigate whether bevacizumab is non-inferior to aflibercept with respect to visual acuity (VA) in eyes with ME associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO). 7,8 Between September 2014 and November 2015, 305 patients with CRVO and 57 patients with HRVO were enrolled at 66 private practice or academic centers in the United States and randomly assigned to receive intravitreal injection of bevacizumab (1.25 mg) or aflibercept (2.0 mg) at randomization and every 4 weeks through Month 5. The primary outcome is change from baseline in best-corrected electronic Early Treatment Diabetic Retinopathy Study (e-ETDRS) VA letter score (VALS) at Month 6, with a non-inferiority margin of 5.…”

“…The primary outcome is change from baseline in best-corrected electronic Early Treatment Diabetic Retinopathy Study (e-ETDRS) VA letter score (VALS) at Month 6, with a non-inferiority margin of 5. 7,8 The purpose of the current report is to describe the baseline patient-reported vision-related function, measured with the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), 9–11 in patients with ME secondary to CRVO or HRVO in SCORE2; to evaluate the relationship between NEI-VFQ-25 scores and 1) visual acuity and 2) central retinal thickness (assessed by central subfield thickness [CST] on spectral domain optical coherence tomography [SD-OCT]) at baseline; and to compare the baseline NEI-VFQ-25 scores of SCORE2 participants with those of normal vision reference populations and patients in other retinal vein occlusion clinical trials.…”

A semi-automated machine-learning based workflow for ellipsoid zone analysis in eyes with macular edema: SCORE2 pilot study

“…The SCORE2 design and methods have been previously described in detail. [18] In summary, 362 participants were randomized to receive either intravitreal bevacizumab or aflibercept. The study visits were conducted per protocol with treatment provided per protocol from baseline through month 12, and then at the discretion of the investigator thereafter.…”