Session Title: Free Paper Session 14: AMD IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 17:30
Venue: Room 111
First Author: : C.Tan SINGAPORE
Co Author(s): : T. Guerin P. Margaron T. Lim
The EVEREST II study evaluated the efficacy and safety of ranibizumab 0.5 mg (RBZ) + verteporfin photodynamic therapy (vPDT) vs RBZ monotherapy in patients with symptomatic polypoidal choroidal vasculopathy (PCV). Here we report polyp responses to RBZ+vPDT vs RBZ monotherapy on indocyanine green angiograms (ICGA) within the first 12 months of the study and the predictors of complete polyp regression at Month (M) 12.
EVEREST II (NCT01846273) is a 24-month, phase IV, double-masked, multicentre study that enrolled Asian patients with symptomatic macular PCV.
A total of 322 eyes were randomized 1:1 to receive RBZ + vPDT (n=168) or RBZ monotherapy (n=154). Study eye eligibility was confirmed by the central reading centre (Fundus Image Reading centre; FIRC) based on ICGA and colour fundus photography using specified diagnostic criteria. The presence and size of polyps were assessed on ICGA by the FIRC at baseline, M3, M6, and M12. The predictors of complete polyp regression at M12 were studied by estimating the probability of complete polyp regression at M12, using logistic regression using demographic, ocular, anatomic, and angiographic parameters at either baseline or M3, which were evaluated in two separate models. Each possible predictor was first assessed by a univariate model, and variables with a p-value <0.2 in the univariate model were then included in a backward elimination multiple regression analysis, with a significance level of 0.05.
Baseline ICGA characteristics were comparable between both treatment groups. At baseline, mean polyp area (±standard deviation; SD) was 0.411 (0.433) mm2 and 0.375 (0.330) mm2 in the RBZ+vPDT and RBZ monotherapy groups, respectively. At M3, 71.4% of the patients treated with RBZ+vPDT had complete polyp regression that remained stable at M6 and M12 (71.3% and 69.7%, respectively). In the RBZ monotherapy group, it increased from 23.3% at M3 to 28.0% at M6 and 33.8% at M12. In patients with complete polyp closure at M3 in the RBZ+vPDT group, 90.5% and 79.8% had complete polyp closure at M6 and M12, respectively. Treatment with combination therapy (odds ratio [OR] 4.74 in the baseline model and 4.69 in the M3 model), absence of pulsation of nodule at baseline (OR 2.70), and branched vascular network size at M3 (OR 0.91) were associated with a higher probability of complete polyp regression at M12. The percent mean reduction in polyp area from baseline at M3 was 85.9% and 42.1% in the RBZ+vPDT group and RBZ monotherapy groups, respectively. At M12, the percent mean reductions in polyp area from baseline were 90.4% and 60.0% in the RBZ+vPDT and RBZ monotherapy groups, respectively.
After 1 year, combination therapy evoked at least twice as much complete polyp regression and a larger reduction in polyp area than RBZ monotherpay. Most of the polyps in the lesions treated with combination therapy were closed at Month 3 and remained closed thereafter. The findings also provide some information on the angiographic parameters that may impact the response of PCV lesions to both treatments.