Evaluation of polypoidal choroidal vasculopathy lesions on indocyanine green angiograms in the first year of the EVEREST II study

Abstract

Purpose : To report polyps and branching vascular network (BVN) responses to ranibizumab 0.5 mg (RBZ) + verteporfin photodynamic therapy (vPDT) vs RBZ monotherapy on indocyanine green angiograms (ICGA) within the first 12 months of the EVEREST II (NCT01846273) study.

Methods : This 24-month, phase IV, double-masked, multicenter study included 322 eyes from Asian patients with symptomatic macular polypoidal choroidal vasculopathy (PCV) who were randomized 1:1 to receive RBZ + vPDT (n = 168) or RBZ monotherapy (n = 154). Study eye eligibility was confirmed by the central reading center (FIRC) using ICGA and color fundus photography using specified diagnostic criteria. Presence and size of polyps and BVN were assessed on ICGA by the reading center at baseline, Month (M) 3, M6, and M12.

Results : Baseline ICGA characteristics were well-balanced between both treatment arms. Complete polyp regression was found in 71.4% of patients treated with RBZ + vPDT at M3 and was thereafter stable (71.3% at M6 and 69.7% at M12), whereas it increased from 23.3% at M3 to 28.0% at M6 and 33.8% at M12 for RBZ monotherapy. The area of polyps still active at M3 decreased on average (± SD) by 0.257 ± 0.267 mm² from baseline in the RBZ + vPDT arm vs 0.132 ± 0.287 mm² in the RBZ monotherapy arm; at M12, the reductions in polyp area from baseline were 0.243 ± 0.350 mm² and 0.112 ± 0.230 mm², respectively. BVN was present in 94.4% of patients at baseline. Among this BVN cohort, BVN was not detected in 22.2% at M3, 15.3% at M6, and 6.0% at M12 in the combination arm vs 4.3%, 7.1%, and 4.5% for RBZ monotherapy, respectively. In RBZ + vPDT patients with open BVN, BVN area initially increased from a mean (± SD) of 3.270 ± 2.725 mm² at baseline to 3.421 ± 2.714 mm² at M6, compared to a more marked increase from 2.640 ± 2.246 mm² at baseline to 3.128 ± 2.619 mm² at M6 for RBZ monotherapy. However, the overall increase in BVN area from baseline at M12 was comparable between both arms (0.622 ± 1.846 mm² for RBZ + vPDT vs 0.736 ± 1.628 mm² for RBZ monotherapy).

Conclusions : Whereas the combination of prompt RBZ + vPDT therapy moderately and transiently impacted BVN closure and area in PCV patients, combination therapy evoked at least twice as much complete polyp regression and a larger reduction in polyp area than RBZ alone.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.