title: Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies.
abstract: To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years.
  
  
  
  Two similarly designed phase 3 trials: VISTADMEand VIVIDDME.
  
  
  
  Patients (eyes; n = 872) with central-involved DME.
  
  
  
  Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. From week 100, laser control patients who had not received IAI rescue treatment received IAI as needed per retreatment criteria.
  
  
  
  The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 52. We report the 148-week results.
  
  
  
  Mean BCVA gain from baseline to week 148 with IAI 2q4, IAI 2q8, and laser control was 10.4, 10.5, and 1.4 letters (P < 0.0001) in VISTA and 10.3, 11.7, and 1.6 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 148 was 42.9%, 35.8%, and 13.6% (P < 0.0001) in VISTA and 41.2%, 42.2%, and 18.9% (P < 0.0001) in VIVID, respectively. Greater proportions of eyes treated with IAI 2q4 and IAI 2q8 versus those treated with laser control had an improvement of ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score in both VISTA (29.9% and 34.4% vs. 20.1% [P = 0.0350, IAI 2q4; P = 0.0052, IAI 2q8]) and VIVID (44.3% and 47.8% vs. 17.4% [P < 0.0001 for both]). In an integrated safety analysis, the most frequent ocular serious adverse event was cataract (3.1%, 2.1%, 0.3% for 2q4, 2q8, and control).
  
  
  
  Visual improvements observed with both IAI regimens (over laser control) at weeks 52 and 100 were maintained at week 148, with similar overall efficacy in the IAI 2q4 and IAI 2q8 groups. Treatment with IAI also had positive effects on the DRSS score. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.
authors.affiliation: Ophthalmic Consultants of Boston, Boston, Massachusetts.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Heier
authors.affiliation: Service d'ophtalmologie, CHU de Bordeaux, France; University Bordeaux, ISPED, F-33000 Bordeaux, Bordeaux, France; Inserm, U1219 - Bordeaux Population Health Research Center, F-33000 Bordeaux, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Korobelnik
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: Ocular Imaging Research and Reading Center, Omaha, Nebraska.
authors.forename: Diana V
authors.initials: DV
authors.lastname: Do
authors.affiliation: Department of Ophthalmology, University of Padova, Padova, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Midena
authors.affiliation: Retina-Vitreous Associates Medical Group, Beverly Hills, California.
authors.forename: David S
authors.initials: DS
authors.lastname: Boyer
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: Ocular Imaging Research and Reading 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: 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: Department of Ophthalmology, University of Bonn, Bonn, Germany. Electronic address: Frank.Holz@ukb.uni-bonn.de.
authors.forename: Frank G
authors.initials: FG
authors.lastname: Holz
mesh_terms: D000368:Aged; D003930:Diabetic Retinopathy / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation / Q000379:methods*; D008266:Macula Lutea / Q000473:pathology*; D008269:Macular Edema / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage*; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D012171:Retinal Vessels / Q000473:pathology; D012189:Retrospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity
chemical_list: D011993:Recombinant Fusion Proteins; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor