title: EXTEND II: an open-label phase III multicentre study to evaluate efficacy and safety of ranibizumab in Chinese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of monthly ranibizumab 0.5 mg in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD).
  
  
  METHODS
  A 12-month open-label single-arm multicenter phase III study that included treatment-naïve (study eye) patients with primary/recurrent subfoveal CNV secondary to AMD. Patients (N = 114) aged ≥50 years with best-corrected visual acuity (BCVA) of 73-24 letters were treated with monthly ranibizumab for 12 months. Main outcomes were mean BCVA change from baseline to month 4 (primary endpoint) and over time to month 12, effects of ranibizumab treatment on retinal structure (months 4 and 12), and safety.
  
  
  RESULTS
  Ranibizumab led to significant improvements in mean BCVA ± standard error (SE) at both months 4 and 12 versus baseline (+9.5 ± 1.10 letters, 95 % confidence interval [CI] 7.3-11.7, and +12.7 ± 1.14 letters, 95 % CI 10.4-14.9, respectively, both P < 0.0001). Ranibizumab prevented loss of vision (≥0 letters BCVA gain) in 91.2 % of patients. Mean central retinal thickness ± SE reduced from baseline to month 12 (-119.9 ± 12.97 µm, 95 % CI -145.59 to -94.20, P < 0.0001). No new safety findings were reported in this study.
  
  
  CONCLUSIONS
  Ranibizumab administered monthly over 12 months was effective in improving BCVA and was well-tolerated in Chinese nAMD patients.
authors.affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, 1, Shuai Fu Yuan, Dongcheng District, Beijing, 100730, China, zhjialiang@163.com.
authors.forename: Jialiang
authors.initials: J
authors.lastname: Zhao
authors.forename: Xiaoxin
authors.initials: X
authors.lastname: Li
authors.forename: Shibo
authors.initials: S
authors.lastname: Tang
authors.forename: Gezhi
authors.initials: G
authors.lastname: Xu
authors.forename: Xun
authors.initials: X
authors.lastname: Xu
authors.forename: Feng
authors.initials: F
authors.lastname: Zhang
authors.forename: Meixia
authors.initials: M
authors.lastname: Zhang
authors.forename: Jila
authors.initials: J
authors.lastname: Shamsazar
authors.forename: Stefan
authors.initials: S
authors.lastname: Pilz
authors.forename: Annette
authors.initials: A
authors.lastname: Nieweg
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects*; D044466:Asian People; D020256:Choroidal Neovascularization / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000188:drug therapy*; D008297:Male; D000069579:Ranibizumab
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab