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

• Published in: Retina (Philadelphia, Pa.) Vol. 32; no. 8; p. 1453
• Main Authors: Koh, Adrian, Lee, Won Ki, Chen, Lee-Jen, Chen, Shih-Jen, Hashad, Yehia, Kim, Hakyoung, Lai, Timothy Y, Pilz, Stefan, Ruamviboonsuk, Paisan, Tokaji, Erika, Weisberger, Annemarie, Lim, Tock H
• Format: Journal Article
• Language: English
• Published: United States 01.09.2012
• Subjects: Aged; Angiogenesis Inhibitors - adverse effects; Angiogenesis Inhibitors - therapeutic use; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Choroid - blood supply; Choroid Diseases - diagnosis; Choroid Diseases - drug therapy; Choroid Diseases - physiopathology; Coloring Agents; Combined Modality Therapy; Double-Blind Method; Female; Fluorescein Angiography; Humans; Indocyanine Green; Intravitreal Injections; Male; Middle Aged; Photochemotherapy; Photosensitizing Agents - adverse effects; Photosensitizing Agents - therapeutic use; Polyps - diagnosis; Polyps - drug therapy; Polyps - physiopathology; Porphyrins - adverse effects; Porphyrins - therapeutic use; Ranibizumab; Treatment Outcome; Visual Acuity - physiology
• ISSN: 1539-2864
• DOI: 10.1097/IAE.0b013e31824f91e8

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. 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. 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. 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.