title: Long-term efficacy and safety of ranibizumab administered pro re nata in Japanese patients with neovascular age-related macular degeneration in the EXTEND-I study.
abstract: OBJECTIVE
  To evaluate the long-term efficacy and safety of ranibizumab administered pro re nata (PRN) in Japanese patients with choroidal neovascularization secondary to age-related macular degeneration during the extension phase of the EXTEND-I study.
  
  
  METHODS
  EXTEND-I, an open-label, multicenter, Phase I ⁄ II study comprised: a single-injection (Group A); a multiple-injection (Groups A and B; the latter consisted of patients who did not participate in the single-injection phase); and an extension phase. In the extension phase, a PRN regimen of ranibizumab (0.3 or 0.5 mg) guided by monthly best-corrected visual acuity (BCVA) score and other ophthalmic examinations was employed. The efficacy variables included the mean BCVA change from Month 12 to the last visit in Group B. Safety was assessed in all patients.
  
  
  RESULTS
  In the extension phase, efficacy was assessed only in Group B patients. The number of ranibizumab injections per year in the 0.3 and 0.5 mg Group B patients was 4.19 and 4.27, respectively. The mean BCVA change (SD) from Month 12 to the last visit was )3.6 (14.82) letters for 0.3 mg (n = 28) and )2.2 (7.92) letters for 0.5 mg groups (n = 33) in Group B. Conjunctival haemorrhage and nasopharyngitis were the most commonly reported adverse events. Of the 13 serious adverse events reported, cerebral infarction (two incidences) was suspected to be study-drug related.
  
  
  CONCLUSIONS
  Pro re nata regimen of ranibizumab guided by monthly BCVA and other ophthalmic examinations appears effective in sustaining the BCVA gained with 12 monthly injections while reducing the number of injections during the extension phase. Ranibizumab was well tolerated during the extension phase.
authors.affiliation: Department of Ophthalmology, Osaka University Medical School, Osaka, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Tano
authors.forename: Masahito
authors.initials: M
authors.lastname: Ohji
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D044466:Asian People / Q000208:ethnology; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008268:Macular Degeneration / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D008297:Male; D000069579:Ranibizumab; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab