Abstract
Purpose :
To compare the efficacy and safety of ranibizumab combined with verteporfin photodynamic therapy (vPDT) and ranibizumab monotherapy in polypoidal choroidal vasculopathy (PCV) patients.
Methods :
EVEREST II (NCT01846273) was a 24-month, phase IV, randomized, double-masked, multicenter study. Treatment-naïve patients (N = 322) diagnosed with symptomatic macular PCV were randomized 1:1 to ranibizumab 0.5 mg and vPDT combination therapy (n=168) or ranibizumab monotherapy (n=154). Best-corrected visual acuity (BCVA) change, complete polyp regression (CPREG), central subfield thickness (CSFT), treatment exposure, and safety outcomes were assessed.
Results :
Overall, 85.1% of patients completed the 24-month study. At Month 12, combination therapy was superior to ranibizumab monotherapy in terms of BCVA gains and CPREG. As pre-defined in the protocol, the remaining patients (n = 41) from the monotherapy arm at baseline were switched to combination therapy afterwards. There were 113 patients from the monotherapy arm at baseline who completed the study before the switch decision. The BCVA gains with combination therapy at Month 12 (9.5 letters) were maintained at 24 months (9.6 letters), the latter being superior to those with ranibizumab monotherapy at 24 months (5.5 letters; p = 0.005; Figure 1). More patients had CPREG at Month 24 in the combination therapy arm (56.6%) compared with the monotherapy arm (26.7%; p < 0.0001). The mean reduction in CSFT from baseline was sustained from Month 3 over 24 months in both arms, with a higher decrease in the combination therapy arm (161.5 µm and 125.0 µm in the combination and monotherapy arms, respectively, at Month 24; p < 0.001). The mean number of ranibizumab injections at 12 and 24 months in the combination arm were 5.1 and 8.1, respectively, in contrast to 7.4 and 12.3 injections in the monotherapy arm. The mean number of vPDT treatments in the combination arm up to Month 24 was 2.2, with 43.6% of patients requiring only the initial vPDT procedure. The safety profile was similar between both arms with no new safety signals.
Conclusions :
Combination therapy of ranibizumab and vPDT was superior to ranibizumab monotherapy in symptomatic PCV patients, in terms of BCVA gains, CPREG, and CSFT reduction over 24 months, with a reduced treatment burden and a comparable safety profile.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.