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Ingrid U Scott, Paul VanVeldhuisen, Michael S Ip, Barbara A Blodi, Neal Oden, Maria Figueroa; Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2): Baseline Characteristics of the SCORE2 Population. Invest. Ophthalmol. Vis. Sci. 2016;57(12):5154.
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© ARVO (1962-2015); The Authors (2016-present)
To describe the baseline characteristics of the SCORE2 participants.
SCORE2 is a clinical trial, funded by the National Eye Institute, designed to assess whether intravitreal bevacizumab is non-inferior to intravitreal aflibercept for the treatment of decreased vision attributable to macular edema due to central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured at Month 6 and follow-up for secondary outcomes at Month 12. The SCORE2 recruitment goal was 360 participants and eligibility criteria were broad, including allowing recruitment of eyes with hemiretinal vein occlusion (HRVO) and prior anti-vascular endothelial growth factor (anti-VEGF) treatment, each limited to no more than 25% of the full SCORE2 sample.
SCORE2 met its enrollment goal and randomized 362 participants from 66 US-based clinical sites between September 17, 2014 and November 19, 2015. The mean age of participants was 68 years (range: 33-98), 76% of participants were white, and 90% were non-Hispanic. Comorbidities included hypertension (76%), diabetes (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 633 microns (range: 300-1203), and the mean number of months the diagnosis of macular edema was made before randomization was 6 months (range: 0-104). There is a modest negative correlation between baseline OCT-CST and VALS (r=-0.26; p<0.001). Sixty-five (18%) SCORE2 participants had been treated previously with anti-VEGF therapy, with these participants having similar baseline VALS and OCT-CST to those without prior anti-VEGF treatment, but longer mean duration of macular edema before randomization (15 months versus 5 months for those without prior anti-VEGF treatment; p<0.001; Wilcoxon two-sample test). Further, 55 of the participants (15%) had a HRVO, with a trend towards better VALS (average of 54 letters) and a shorter duration of macular edema before randomization (average of 2 months) compared with CRVO eyes (VALS of 50 letters, p=0.06; macular edema duration of 7 months, p=0.01).
The SCORE2 cohort is a heterogeneous population which will allow study results to have broad applicability to CRVO and HRVO patients receiving treatment for macular edema.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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