Session Title: Free Paper Session 14: AMD IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 17:24
Venue: Room 111
First Author: : T.Lai HONG KONG
Co Author(s): : T. Guerin P. Margaron C. Tan
The EVEREST II study evaluated the efficacy and safety of ranibizumab 0.5 mg (RBZ) + verteporfin photodynamic therapy (vPDT) versus RBZ monotherapy in patients with symptomatic polypoidal choroidal vasculopathy (PCV). Here we report the anatomical outcomes at Month (M) 12 of the EVEREST II study.
EVEREST II (NCT01846273) is an ongoing 24M, phase IV, double-masked, multicentre study that enrolled Asian patients with symptomatic macular PCV.
A total of 322 eyes were randomized to receive RBZ+vPDT (n=168) or RBZ monotherapy (n=154). Study eye eligibility was confirmed by indocyanine green angiography (ICGA) and colour fundus photography using specified diagnostic criteria. Central subfield thickness (CSFT), presence of intra- or sub-retinal fluid (SRF), and central choroidal thickness (CCT) were assessed on spectral domain optical coherence tomography (SD-OCT) by the central reading centre at baseline, M3, M6, and M12. The probability of fluid free retina at M12 was estimated by logistic regression using demographic, ocular, anatomic, and angiographic parameters at baseline and M3, which were evaluated in two separate models. Each possible predictor was first assessed in a univariate model, and variables with a p-value <0.2 from the univariate model were then included in a backward elimination multiple logistics regression analysis, with a significance level of 0.05.
Baseline anatomical characteristics were well-balanced between the two treatment arms. At M12, the RBZ+vPDT arm showed greater mean CSFT reduction than the RBZ arm (least squares mean: −164.9 μm vs −113.4 μm, p<0.001). At M12, 83.2% and 60.3% patients in the RBZ+vPDT and RBZ arms, respectively, had CSFT <300 μm. Mean CCT change from baseline to M12 was higher in the RBZ+vPDT arm than the RBZ arm (−55.2 μm vs −30.1 μm). CSFT change from baseline at M12 weakly correlated with CCT change from baseline at M12 (Pearson correlation coefficient: RBZ+vPDT, 0.35; and RBZ monotherapy, 0.19). At M3 and M12, 62.0% and 56.8% patients in the RBZ+vPDT arm and 37.1% and 28.7% in the RBZ arm had fluid-free retina, respectively. The proportion of patients with SRF present at baseline, but absent at M3 and M12, was higher with RBZ+vPDT than RBZ monotherapy (M3, 73.0% vs 44.1%; M12, 69.8% vs 39.7%). Treatment with combination therapy (baseline model odds ratio [OR] 3.75 and M3 model OR 2.13) and absence of SRF at M3 (OR 3.10) were associated with a higher probability of fluid-free retina at M12, in contrast to higher CSFT at baseline (OR 0.76/100 µm) or M3 (OR 0.66/100 µm).
These findings are consistent with the primary outcomes of EVEREST II that confirmed that both RBZ and RBZ in combination with vPDT are effective treatment options for patients with PCV. RBZ in combination with vPDT, resulted in additional best-corrected visual acuity improvement and higher polyp regression as well as more marked anatomical benefits over RBZ monotherapy. The results also contribute to the understanding of the anatomical response of PCV lesions to RBZ with or without vPDT.