title: Intravitreal Aflibercept for Diabetic Macular Edema: 100-Week Results From the VISTA and VIVID Studies.
abstract: OBJECTIVE
  To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME).
  
  
  METHODS
  Two similarly designed, randomized, phase 3 trials, VISTA(DME) and VIVID(DME).
  
  
  METHODS
  Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement.
  
  
  METHODS
  Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control.
  
  
  METHODS
  The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained ≥15 letters, and proportion of eyes with a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score.
  
  
  RESULTS
  Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost ≥15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a ≥2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control).
  
  
  CONCLUSIONS
  In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.
authors.affiliation: Retina Consultants of Houston, Houston, Texas.
authors.forename: David M
authors.initials: DM
authors.lastname: Brown
authors.affiliation: Medical University of Vienna, Vienna, Austria.
authors.forename: Ursula
authors.initials: U
authors.lastname: Schmidt-Erfurth
authors.affiliation: Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska.
authors.forename: Diana V
authors.initials: DV
authors.lastname: Do
authors.affiliation: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors.forename: Frank G
authors.initials: FG
authors.lastname: Holz
authors.affiliation: Retina-Vitreous Associates Medical Group, Beverly Hills, California.
authors.forename: David S
authors.initials: DS
authors.lastname: Boyer
authors.affiliation: Department of Ophthalmology, University of Padova, Padova, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Midena
authors.affiliation: Ophthalmic Consultants of Boston and Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Heier
authors.affiliation: Nagoya University Hospital, Nagoya, Japan.
authors.forename: Hiroko
authors.initials: H
authors.lastname: Terasaki
authors.affiliation: Cole Eye Institute, Cleveland, Ohio.
authors.forename: Peter K
authors.initials: PK
authors.lastname: Kaiser
authors.affiliation: Southeast Retina Center, Augusta, Georgia.
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Marcus
authors.affiliation: Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska.
authors.forename: Quan D
authors.initials: QD
authors.lastname: Nguyen
authors.affiliation: Department of Ophthalmology, Duke University, Durham, North Carolina.
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Jaffe
authors.affiliation: Vitreous-Retina-Macula Consultants of New York, New York, New York.
authors.forename: Jason S
authors.initials: JS
authors.lastname: Slakter
authors.affiliation: Medical University of Vienna, Vienna, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Simader
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Yuhwen
authors.initials: Y
authors.lastname: Soo
authors.affiliation: Bayer HealthCare, Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmelter
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: George D
authors.initials: GD
authors.lastname: Yancopoulos
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Neil
authors.initials: N
authors.lastname: Stahl
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Robert
authors.initials: R
authors.lastname: Vitti
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: Berliner
authors.affiliation: Bayer HealthCare, Berlin, Germany; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Zeitz
authors.affiliation: Bayer HealthCare, Berlin, Germany.
authors.forename: Carola
authors.initials: C
authors.lastname: Metzig
authors.affiliation: Service d'ophtalmologie, Hôpital Pellegrin-CHU de Bordeaux, Bordeaux, France; Université Bordeaux Segalen, Bordeaux, France; INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France. Electronic address: jean-francois.korobelnik@chu-bordeaux.fr.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Korobelnik
mesh_terms: D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage* / Q000009:adverse effects; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D018434:Sickness Impact Profile; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor