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T. Y. Lai, Everest Study Group; Verteporfin PDT and Ranibizumab Combination Therapy for Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV): EVEREST Results. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2228.
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Combining verteporfin PDT (vPDT; angio-occlusive) + ranibizumab (anti-angiogenic) may have synergistic effect in treating PCV. EVEREST is the first ICGA-guided RCT to assess the effect of vPDT combined with ranibizumab or alone, vs ranibizumab monotherapy in patients (pts) with symptomatic macular PCV.
In this 6-month (M) study, 61 Asian pts (central reading center-confirmed PCV) were randomized: vPDT+ranibizumab (combination), vPDT (+sham injection), or 0.5mg ranibizumab (+verteporfin placebo PDT). Pts received 1 vPDT or verteporfin placebo PDT on Day1 and 3 consecutive monthly ranibizumab/sham injections starting Day1. From M3 through M5, pts were retreated according to protocol specific re-treatment criteria, driven by polyp regression and included BCVA loss, leakage on FA, and treatment interval as per European labels. Primary endpoint: proportion of pts with complete regression of polyps (CRP) on ICGA at M6. Key secondary endpoints: changes in mean BCVA and central retinal thickness (CRT) from baseline over 6 months, number of re-txs as from M3, and safety assessments.
59 (96.7%) pts completed the study. Proportion of pts with CRP at M6 were combination, 77.8%; vPDT, 71.4%; and ranibizumab, 28.6% (difference vs. ranibizumab: combination, 49.2%, p=0.0018; vPDT, 42.9%, p=0.0037). Mean BCVA change at M6 was +10.9, +7.5, and +9.2 for the combination, vPDT, and ranibizumab groups, respectively. Mean CRT change at M6 was (µm):-145.6, -98.1, and -65.7 for combination, vPDT, and ranibizumab groups, respectively. Mean number of ranibizumab re-txs were 1.1 (combination), 1.2 (vPDT), and 2.2 (ranibizumab). There were no reports of ocular SAEs or cerebrovascular accident during the study.
EVEREST demonstrates the superior efficacy of standard fluence vPDT in combination with ranibizumab or alone vs. ranibizumab monotherapy with regard to CRP at M6. Pts in all groups gained vision, with pts in the combination group achieving the highest gains. All therapies were well tolerated and the safety findings were consistent with the established safety profiles of vPDT and ranibizumab.
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