title: Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study.
abstract: OBJECTIVE
  To evaluate efficacy and safety of intravitreal aflibercept (IVT-AFL) in Japanese patients with wet age-related macular degeneration (wAMD) from the VIEW 2 trial.
  
  
  METHODS
  In this double-masked study, patients were randomised to: 0.5 mg IVT-AFL every 4 weeks (0.5q4); 2 mg IVT-AFL every 4 weeks (2q4); 2 mg IVT-AFL every 8 weeks (2q8) after 3 monthly injections; or 0.5 mg ranibizumab every 4 weeks (Rq4). Main efficacy outcomes included vision maintenance and best-corrected visual acuity (BCVA) at week 52.
  
  
  RESULTS
  At week 52, all Japanese patients in the IVT-AFL groups (n=70) maintained vision, compared with 96% of Japanese patients (n=23/24) treated with ranibizumab. Japanese patients in all treatment groups showed improvement in BCVA after treatment. The Rq4, 2q4 and 2q8 groups experienced similar gains in BCVA from baseline. The 0.5q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline. Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude. Ocular treatment-emergent adverse events were balanced across treatment groups.
  
  
  CONCLUSIONS
  IVT-AFL was effective and well tolerated in Japanese patients. Outcomes in this population were consistent with those in the overall VIEW 2 population.
  
  
  BACKGROUND
  NCT00637377.
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: 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, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Fumi
authors.initials: F
authors.lastname: Gomi
authors.affiliation: Department of Ophthalmology, Nihon University School of Medicine, Tokyo, Japan.
authors.forename: Mitsuko
authors.initials: M
authors.lastname: Yuzawa
authors.affiliation: Department of Ophthalmology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Iida
authors.affiliation: Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan.
authors.forename: Miki
authors.initials: M
authors.lastname: Honda
authors.affiliation: Bayer Yakuhin, Ltd., Osaka, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Nishijo
authors.affiliation: Bayer HealthCare Pharmaceuticals, Berlin, Germany.
authors.forename: Olaf
authors.initials: O
authors.lastname: Sowade
authors.affiliation: Bayer Yakuhin, Ltd., Osaka, Japan.
authors.forename: Tetsushi
authors.initials: T
authors.lastname: Komori
authors.affiliation: Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
authors.forename: Ursula
authors.initials: U
authors.lastname: Schmidt-Erfurth
authors.affiliation: Vienna Reading Center (VRC), Medical University of Vienna, Vienna, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Simader
authors.affiliation: Oxford Eye Hospital, University of Oxford, Oxford, UK.
authors.forename: Victor
authors.initials: V
authors.lastname: Chong
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D040262:Receptors, Vascular Endothelial Growth Factor / Q000009:adverse effects / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects; D057135:Wet Macular Degeneration / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology
chemical_list: D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor
keywords: Angiogenesis; Clinical Trial; Macula; Neovascularisation; Retina
references.citation: Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5914-9
references.pmid: 20574013
references.citation: Am J Ophthalmol. 2009 Jun;147(6):1037-41, 1041.e1-2
references.pmid: 19268887
references.citation: Ophthalmology. 2013 Jan;120(1):122-9
references.pmid: 23047002
references.citation: Br J Ophthalmol. 2001 Oct;85(10):1153-7
references.pmid: 11567955
references.citation: Lancet. 2012 May 5;379(9827):1728-38
references.pmid: 22559899
references.citation: Jpn J Ophthalmol. 2010 Mar;54(2):124-8
references.pmid: 20401560
references.citation: Ophthalmology. 2010 May;117(5):928-38
references.pmid: 20132989
references.citation: Acta Ophthalmol. 2011 May;89(3):208-17
references.pmid: 21232078
references.citation: BMC Ophthalmol. 2013 Apr 04;13:10
references.pmid: 23557322
references.citation: Retina. 2012 Jul;32(7):1250-9
references.pmid: 22446886
references.citation: Ophthalmology. 2008 Aug;115(8):1376-81, 1381.e1-2
references.pmid: 18222000
references.citation: Ophthalmic Epidemiol. 2011 Dec;18(6):253-8
references.pmid: 22053833
references.citation: Am J Ophthalmol. 2007 Jul;144(1):15-22
references.pmid: 17509509
references.citation: Br J Ophthalmol. 2000 Sep;84(9):1018-23
references.pmid: 10966957
references.citation: Eye (Lond). 2003 May;17(4):457-66
references.pmid: 12802343
references.citation: Acta Ophthalmol. 2010 May;88(3):309-16
references.pmid: 20163368
references.citation: Ophthalmology. 2012 Dec;119(12):2537-48
references.pmid: 23084240