title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Eye & Retina Surgeons Clinic, Camden Medical Centre, Singapore, Singapore.
authors.forename: Adrian
authors.initials: A
authors.lastname: Koh
authors.forename: Won Ki
authors.initials: WK
authors.lastname: Lee
authors.forename: Lee-Jen
authors.initials: LJ
authors.lastname: Chen
authors.forename: Shih-Jen
authors.initials: SJ
authors.lastname: Chen
authors.forename: Yehia
authors.initials: Y
authors.lastname: Hashad
authors.forename: Hakyoung
authors.initials: H
authors.lastname: Kim
authors.forename: Timothy Y
authors.initials: TY
authors.lastname: Lai
authors.forename: Stefan
authors.initials: S
authors.lastname: Pilz
authors.forename: Paisan
authors.initials: P
authors.lastname: Ruamviboonsuk
authors.forename: Erika
authors.initials: E
authors.lastname: Tokaji
authors.forename: Annemarie
authors.initials: A
authors.lastname: Weisberger
authors.forename: Tock H
authors.initials: TH
authors.lastname: Lim
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D002829:Choroid / Q000098:blood supply; D015862:Choroid Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004396:Coloring Agents; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007208:Indocyanine Green; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011127:Polyps / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011166:Porphyrins / Q000009:adverse effects / Q000627:therapeutic use*; D000069579:Ranibizumab; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D004396:Coloring Agents; D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin; D007208:Indocyanine Green; D000069579:Ranibizumab