title: Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration.
abstract: OBJECTIVE
  To evaluate the effect of intravitreal aflibercept injection on visual function in wet age-related macular degeneration (AMD).
  
  
  METHODS
  Prospective, multicenter, double-masked, active-controlled, parallel-group, randomized phase 3 clinical studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW] 1 and 2 [clinicaltrials.gov identifiers, NCT00509795 and NCT00637377, respectively]).
  
  
  METHODS
  Patients (n=2419) with active, treatment-naïve, exudative AMD. This analysis included patients who received intravitreal aflibercept 2.0 mg every 8 weeks (2q8; n=607) or ranibizumab 0.5 mg every 4 weeks (0.5q4; n=595).
  
  
  METHODS
  Patients were randomized 1:1:1:1 to receive intravitreal aflibercept 2q8 (after 3 initial monthly doses), intravitreal aflibercept 2q4, intravitreal aflibercept 0.5q4, or ranibizumab 0.5q4 in the study eye. Patients in the intravitreal aflibercept 2q8 group received a sham injection alternating with active treatment.
  
  
  METHODS
  The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was administered at baseline and at weeks 12, 24, 36, and 52. The NEI VFQ-25 subscale scores were compared between intravitreal aflibercept 2q8 and ranibizumab 0.5q4 treatment arms, the approved dosing for each agent worldwide. Change in composite NEI VFQ-25 score was evaluated based on categorical change in visual acuity (worsened, unchanged, improved).
  
  
  RESULTS
  Baseline NEI VFQ-25 scores were similar for both treatments in both studies. Mean change from baseline to 52 weeks was similar for ranibizumab 0.5q4 and intravitreal aflibercept 2q8 across all 12 subscales, with the greatest improvements noted for mental health and general vision (9.0-11.6 points, both treatments, both studies). Improvement of 4 points or more (both treatments, both studies) also was observed for subscales near vision, distance vision, role difficulties, and dependency. Mean change from baseline to 52 weeks in NEI VFQ-25 composite score (pooled data) stratified by clinical response showed meaningful improvement only in patients who gained 5 Early Treatment Diabetic Retinopathy letters or more (7.3 and 7.8 points for intravitreal aflibercept 2q8 and ranibizumab 0.5q4, respectively).
  
  
  CONCLUSIONS
  Visual function outcomes were similar across all NEI VFQ-25 subscales over 52 weeks for intravitreal aflibercept 2q8 and ranibizumab 0.5q4, with clinically meaningful improvement recorded in 6 of 12 subscales.
authors.affiliation: Department of Ophthalmology, Nihon University School of Medicine, Surugadai, Kanda, Chiyoda-ku, Tokyo, Japan. Electronic address: yuzawa.mitsuko@nihon-u.ac.jp.
authors.forename: Mitsuko
authors.initials: M
authors.lastname: Yuzawa
authors.affiliation: Department of Ophthalmology, Nihon University School of Medicine, Surugadai, Kanda, Chiyoda-ku, Tokyo, Japan.
authors.forename: Kyoko
authors.initials: K
authors.lastname: Fujita
authors.affiliation: Bayer Pharma AG, Berlin, Germany.
authors.forename: Kim U
authors.initials: KU
authors.lastname: Wittrup-Jensen
authors.affiliation: Bayer Pharma AG, Berlin, Germany.
authors.forename: Christiane
authors.initials: C
authors.lastname: Norenberg
authors.affiliation: Bayer Pharma AG, Berlin, Germany; Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Zeitz
authors.affiliation: Health Economics and Outcomes Research, Bayer Yakuhin Ltd, Umeda, Kita-ku, Osaka, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Adachi
authors.affiliation: Health Economics and Outcomes Research, Bayer Yakuhin Ltd, Umeda, Kita-ku, Osaka, Japan.
authors.forename: Edward C Y
authors.initials: EC
authors.lastname: Wang
authors.affiliation: Ophthalmic Consultants of Boston and Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Heier
authors.affiliation: Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Peter
authors.initials: P
authors.lastname: Kaiser
authors.affiliation: Oxford Eye Hospital, University of Oxford, Oxford, United Kingdom.
authors.forename: Victor
authors.initials: V
authors.lastname: Chong
authors.affiliation: Service d'ophtalmologie, Hôpital Pellegrin-CHU de Bordeaux and Université Bordeaux Segalen, Bordeaux, France; INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France.
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Korobelnik
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D011446:Prospective Studies; D000069579:Ranibizumab; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors*; D014792:Visual Acuity / Q000502:physiology*; D057135:Wet Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D011993:Recombinant Fusion Proteins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor; D000069579:Ranibizumab