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Tock H Lim, Chrystel Feller, Philippe Margaron, Colin S Tan; Baseline characteristics of polypoidal choroidal vasculopathy in the EVEREST II Study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):901.
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© ARVO (1962-2015); The Authors (2016-present)
EVEREST II (NCT01846273) is a large, randomized, controlled study in patients with polypoidal choroidal vasculopathy (PCV) across 41 Asian sites. Here we describe the baseline characteristics of PCV lesions in the EVEREST II study.
In a 24-month, phase IV, double-masked, multicenter study, patients with PCV were randomized 1:1 to receive ranibizumab + verteporfin photodynamic therapy or ranibizumab monotherapy. All patients were assessed as per the standardized multimodal imaging protocol; images were evaluated centrally by the Fundus Image Reading Center (FIRC, Singapore). PCV was confirmed by FIRC using a standardized reading protocol with well-defined diagnostic criteria (modified from EVEREST I). Baseline characteristics were assessed using confocal scanning laser ophthalmoscopy ICGA, color fundus (CF), fluorescein angiography (FA), and spectral domain optical coherence angiography (SD-OCT).
Of the 492 screened patients, 317 of 322 randomized were diagnosed as definitive PCV by FIRC. At baseline, the mean polyp size was 0.395 mm2 and 94.4% patients showed presence of branching vascular network (BVN) with a mean BVN size of 2.89 mm2. Nearly, 30.4% of patients had ≥5 polyps (Figure). Nodular appearance on stereo-pair viewing, hypofluorescent halo, and pulsation of nodule on dynamic ICGA was observed in 95.3%, 69.6%, and 15.8% of patients, respectively. CF showed an orange nodule in 64.6% and massive submacular hemorrhage in 10.6% of patients. In FA, occult, minimally classic, and predominantly classic lesion types were observed in 81.7%, 7.8%, and 0.6%, patients, respectively. SD-OCT showed the presence of subretinal fluid in 95.7%, intraretinal fluid in 57.5%, intraretinal cystoid changes in 32.6%, and features suggestive of polyps in 82.0% of patients. Baseline characteristics were well-balanced between the two treatment arms.
EVEREST II provided a large prospectively collected image dataset with a standardized multimodal imaging protocol employing a well-defined diagnostic criteria. The study provided valuable insights into baseline characteristics of Asian PCV lesions. Most PCV cases showed nodular hyperfluorescence and BVN on ICGA, occult pattern of leakage on FA, SD-OCT features of the polypoidal structures, and fluid in the subretinal space.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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