A Multicentre Double-masked Randomised Controlled Non-Inferiority Trial comparing clinical and cost effectiveness of intravitreal therapy with ranibizumab (Lucentis) vs aflibercept (Eylea) vs bevacizumab (Avastin) for Macular Oedema due to Central Retinal Vein Occlusion [LEAVO]: Baseline patient sociodemographic and ocular characteristics.

Abstract

Purpose : There has been no direct comparison of the clinical and cost effectiveness of intravitreal therapy with ranibizumab, aflibercept and bevacizumab in macular oedema (MO) due to central retinal vein occlusion (CRVO) in a large randomised clinical trial. The baseline sociodemographic and ocular characteristics of patients enrolled in the LEAVO study are presented.

Methods : Patients (n=463) with MO due to CRVO, baseline BCVA of 19 to 78 letters were recruited in 44 UK Centres, randomised 1:1:1 to bevacizumab, aflibercept or ranibizumab and treated to 100 weeks with four mandated monthly anti-VEGF intravitreal injections followed by repeated injection if pre specified retreatment criteria were met. The primary outcome is change in BCVA from baseline to 100 weeks in all patients. Baseline age, gender, ethnicity, prior treatment, duration of CRVO, glaucoma history, study eye BCVA letter score , IOP, OCT mean central subfield thickness (CST) and macular volume are presented by masked subgroup.

Results : Key baseline sociodemographic and ocular characteristic data are presented in Table 1. (subject to minor change prior to datalock). In addition, 94% of patients in subgroup A, 93% in B and 93% in C were white, 5% in A and B and 6% in C were asian. 6% in subgroup A, 8% in B and 9% in C had pre existing glaucoma and IOP mmHg (SD) was 15.8(3.3), 16.3(3.7) and 16.6(5.1) respectively. OCT mean (SD) total volume (mm³) was 12.0 (3.0) in subgroup A, 12.8(3.0) in B and 12.4(3.4) in C.

Conclusions : The data indicate that baseline patient demographics and ocular characteristics are well balanced across subgroups, last patient last visit is 2018 with primary outcome data due early 2019.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

CST= central subfield thickness, BCVA= best corrected visual acuity (refracted).