Session Title: Free Paper Session 27: AMD VI
Session Date/Time: Sunday 10/09/2017 | 12:00-13:30
Paper Time: 13:00
Venue: Room 117
First Author: : T.Lim SINGAPORE
Co Author(s): : C. Feller 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 describe the baseline characteristics of PCV lesions in the EVEREST II study.
EVEREST II (NCT01846273) is a 24-month, phase IV, double-masked, multicentre study that enrolled Asian patients with symptomatic macular PCV.
Eligible patients were randomized 1:1 to receiveRBZ + vPDT or RBZ monotherapy. All patients were assessed as per the standardized multimodal imaging protocol; images were evaluated centrally by the Fundus Image Reading centre (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 indocyanine green angiography (ICGA) and fluorescein angiography (FA), colour fundus photography (CFP), and spectral domain optical coherence tomography (SD-OCT).
Of the 492 screened patients, 322 were randomized and 317 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. Overall, 30.4% of patients had ≥5 polyps. Nodular appearance on stereo-pair viewing, hypofluorescent halo, and pulsation of nodule on dynamic ICGA were observed in 95.3%, 69.6%, and 15.8% of patients, respectively. CFP showed an orange nodule in 64.6% and massive submacular haemhorrage in 10.6% 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 cysts in 32.6% patients, and features suggestive of polyps in 82.0% patients. Baseline characteristics were well-balanced between the two treatment arms.
EVEREST II provided one of the largest prospectively collected image datasets with a standardized multimodal imaging protocol employing a well-defined diagnostic criteria. The study provided valuable insights into baseline characteristics of PCV lesions in Asian patients. 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 mainly in the subretinal space.