EVEREST study: efficacy and safety of verteporfin photodynamic therapy in
combination with ranibizumab or alone versus ranibizumab monotherapy in patients
with symptomatic macular polypoidal choroidal vasculopathy.
Author(s): Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk
P, Tokaji E, Weisberger A, Lim TH.
Affiliation(s): Eye & Retina Surgeons Clinic, Camden Medical Centre, Singapore, Singapore.
Publication date & source: 2012, Retina. , 32(8):1453-64
PURPOSE: To assess the effects of verteporfin photodynamic therapy (PDT) combined
with ranibizumab or alone versus ranibizumab monotherapy in patients with
symptomatic macular polypoidal choroidal vasculopathy.
METHODS: In this multicenter, double-masked, primarily indocyanine green
angiography-guided trial, 61 Asian patients were randomized to verteporfin PDT
(standard fluence), ranibizumab 0.5 mg, or the combination. Patients were
administered with verteporfin PDT/placebo and initiated with three consecutive
monthly ranibizumab/sham injections starting Day 1, and re-treated (Months 3-5)
as per predefined criteria. The primary endpoint was the proportion of patients
with indocyanine green angiography-assessed complete regression of polyps at
Month 6. Secondary endpoints included mean change in best-corrected visual acuity
at Month 6 and safety.
RESULTS: At Month 6, verteporfin combined with ranibizumab or alone was superior
to ranibizumab monotherapy in achieving complete polyp regression (77.8% and
71.4% vs. 28.6%; P < 0.01); mean change ± standard deviation in best-corrected
visual acuity (letters) was 10.9 ± 10.9 (verteporfin PDT + ranibizumab), 7.5 ±
10.6 (verteporfin PDT), and 9.2 ± 12.4 (ranibizumab). There were no new safety
findings with either drug used alone or in combination.
CONCLUSION: Verteporfin PDT combined with ranibizumab 0.5 mg or alone was
superior to ranibizumab monotherapy in achieving complete regression of polyps in
this 6-month study in patients with symptomatic macular polypoidal choroidal
vasculopathy. All treatments were well tolerated over 6 months.
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