Abstract
Purpose :
To evaluate changes in polyps and the branching vascular network (BVN) in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV) treated with ranibizumab 0.5 mg (RBZ) combined with verteporfin photodynamic therapy (vPDT) or RBZ monotherapy over 24 months.
Methods :
EVEREST II (NCT01846273) was a 24-month, phase IV, randomized, double-masked, multicenter study. Treatment-naïve patients (N=322) diagnosed with PCV were randomized 1:1 to RBZ and vPDT combination therapy (n=168) or RBZ monotherapy (n=154). Parameters involving polyps were assessed using indocyanine green angiography (ICGA) by the central reading center at baseline, Months 3, 6, 12, and 24.
Results :
At baseline, the number of polyps in both the treatment arms were comparable; >30.4% of all patients had ≥5 polyps. All cases showed early focal ICGA hyperfluorescence and the majority of patients had BVN (combination therapy arm: 94.0%; monotherapy arm: 94.8%). At Month 12, combination therapy was superior to RBZ monotherapy in achieving complete polyp regression (CPREG; 69.7% vs 33.8%; p<0.0001) and this superiority was maintained at 24 months (56.6% vs 26.7%; p<0.0001; Figure 1). In the combination arm, the proportions of patients with CPREG were comparable at Months 3, 6, and 12 (71.4%, 71.3% and 69.7%, respectively) with a slight decrease at Month 24 (56.6%). In the monotherapy arm, the proportion increased from 21.7% at Month 3 to 30.4% at Month 6 and 32.6% at Month 12 and decreased to some extent at Month 24 (26.7%). Similar CPREG results were observed in patients with ≥5 polyps at baseline in both treatment arms. The percent reduction in total polyp size from baseline was numerically higher in the combination arm than in the monotherapy arm: 65.2% vs 32.8% at Month 12 and 52.3% vs 33.7% at Month 24. Active BVN size increased from baseline in both treatment arms but the increase was lower in the combination arm compared with the monotherapy arm: 19.4% vs 27.4% at Month 12 and 38.9% vs 70% at Month 24.
Conclusions :
RBZ and vPDT combination therapy was superior to RBZ monotherapy in PCV patients in terms of CPREG and was more effective in reducing polyp size and regulating BVN size over 24 months. These results contribute to the understanding of the angiographic parameters that may impact the response of PCV lesions to RBZ with or without vPDT.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.