title: Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion: 52-Week Results of the VIBRANT Study.
abstract: OBJECTIVE
  To determine week 52 efficacy and safety outcomes in eyes with macular edema after branch retinal vein occlusion (BRVO) treated with 2 mg intravitreal aflibercept injection (IAI) compared with grid laser.
  
  
  METHODS
  VIBRANT was a double-masked, randomized, phase 3 trial.
  
  
  METHODS
  Eyes randomized and treated in VIBRANT were followed to week 52.
  
  
  METHODS
  In the IAI group, eyes received IAI every 4 weeks through week 24 and IAI every 8 weeks through week 48 with rescue grid laser if needed at week 36. In the grid laser group, all eyes received grid laser at baseline and, if prespecified rescue criteria were met, 1 additional laser from week 12 to 20 and IAI every 8 weeks after 3 monthly doses from week 24 onward (the laser/IAI group).
  
  
  METHODS
  The primary outcome measure was percentage of eyes with improvement from baseline best-corrected visual acuity (BCVA) letter score ≥15 at week 24. All outcome measures at week 52 were exploratory, and P values are considered nominal.
  
  
  RESULTS
  The percentage of eyes with improvement from baseline letter score ≥15 in the IAI and laser/IAI groups was 52.7% versus 26.7% (P = 0.0003) at week 24 and 57.1% versus 41.1% (P = 0.0296) at week 52. The corresponding mean change from baseline BCVA letter score was 17.0 versus 6.9 (P < 0.0001) at week 24 and 17.1 versus 12.2 (P = 0.0035) at week 52. The mean reduction from baseline central retinal thickness was 280.5 μm versus 128.0 μm (P < 0.0001) at week 24 and 283.9 μm versus 249.3 μm (P = 0.0218) at week 52. In the IAI group, 10.6% of eyes received rescue laser at week 36, and in the laser/IAI group, 80.7% received rescue IAI from week 24 to week 48. Traumatic cataract in 1 eye (1.1%) in the IAI group was the only ocular serious adverse event.
  
  
  CONCLUSIONS
  After 6 monthly IAI, injections every 8 weeks maintained control of macular edema and visual benefits through week 52. In the laser group, rescue IAI given from week 24 onward resulted in substantial visual improvements at week 52.
authors.affiliation: Palmetto Retina Center, West Columbia, South Carolina.
authors.forename: W Lloyd
authors.initials: WL
authors.lastname: Clark
authors.affiliation: Retina-Vitreous Associates Medical Group, Beverly Hills, California.
authors.forename: David S
authors.initials: DS
authors.lastname: Boyer
authors.affiliation: Ophthalmic Consultants of Boston, Boston, Massachusetts.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Heier
authors.affiliation: Retina Consultants of Houston, The Methodist Hospital, Houston, Texas.
authors.forename: David M
authors.initials: DM
authors.lastname: Brown
authors.affiliation: Wills Eye Hospital, Philadelphia, Pennsylvania.
authors.forename: Julia A
authors.initials: JA
authors.lastname: Haller
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: Husain
authors.initials: H
authors.lastname: Kazmi
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: Berliner
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Kristine
authors.initials: K
authors.lastname: Erickson
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Karen W
authors.initials: KW
authors.lastname: Chu
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Yuhwen
authors.initials: Y
authors.lastname: Soo
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Yenchieh
authors.initials: Y
authors.lastname: Cheng
authors.affiliation: Department of Ophthalmology, The Johns Hopkins School of Medicine, Baltimore, Maryland. Electronic address: pcampo@jhmi.edu.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Campochiaro
mesh_terms: D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D040262:Receptors, Vascular Endothelial Growth Factor / Q000009:adverse effects / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D012170:Retinal Vein Occlusion / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; 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