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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

Adrian Koh, Won Ki Lee, Lee-Jen Chen, Shih-Jen Chen, Yehia Hashad, Hakyoung Kim, Timothy Y Lai, Stefan Pilz, Paisan Ruamviboonsuk, Erika Tokaji, Annemarie Weisberger, Tock H Lim

Retina. 2012 Sep;32(8):1453-64.

PMID: 22426346

Abstract:

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.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP129497785 Verteporfin Verteporfin 129497-78-5 Price
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