title: Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of ranibizumab 0.5 mg in Japanese patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and to support the applicability of the phase III results from Caucasian to Japanese populations.
  
  
  METHODS
  This is a 3-month, open-label, single-arm, multicentre, phase III study. Thirty-one patients (15 BRVO and 16 CRVO) aged ≥18 years with a best-corrected visual acuity (BCVA) letter score of 19-73 (BRVO) or 24-73 (CRVO) were included. The primary end-point was the mean average change in BCVA from baseline to month 1 through month 3 after three consecutive monthly intravitreal injections of ranibizumab 0.5 mg. Secondary end-points were mean change in BCVA and central subfield thickness (CSFT), categorized BCVA, and safety over 3 months.
  
  
  RESULTS
  At month 3, the mean average change in BCVA improved substantially from baseline for BRVO (11.3 letters, p = 0.001) and CRVO (6.7 letters, p = 0.019). The mean BCVA improved (12.8 and 9.1 letters) and the mean CSFT decreased (212.5 and 442.1 μm) from baseline to month 3. At month 3, 26.7% (BRVO) and 31.3% (CRVO) of the patients had a gain of ≥15 letters from baseline. Safety findings in this study were similar to those reported in the previous clinical trials.
  
  
  CONCLUSIONS
  Ranibizumab was effective in improving BCVA and was well tolerated in Japanese patients with BRVO and CRVO. The findings from this study were consistent with those reported in the Caucasian population.
authors.affiliation: Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Kamei
authors.affiliation: Department of Ophthalmology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Hiroko
authors.initials: H
authors.lastname: Terasaki
authors.affiliation: Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Nagahisa
authors.initials: N
authors.lastname: Yoshimura
authors.affiliation: Department of Ophthalmology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
authors.forename: Fumio
authors.initials: F
authors.lastname: Shiraga
authors.affiliation: Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ogura
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Andrea Suhner
authors.initials: AS
authors.lastname: Grotzfeld
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Pilz
authors.affiliation: Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Tatsuro
authors.initials: T
authors.lastname: Ishibashi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People / Q000208:ethnology; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D007564:Japan / Q000453:epidemiology; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069579:Ranibizumab / Q000009:adverse effects / Q000627:therapeutic use*; D012170:Retinal Vein Occlusion / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D016037:Single-Blind Method; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D020533:Angiogenesis Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab
keywords: Japanese; branch retinal vein occlusion; central retinal vein occlusion; macular oedema; ranibizumab; visual impairment