title: Microperimetric assessment of retinal sensitivity in eyes with diabetic macular edema from a phase 2 study of intravitreal aflibercept.
abstract: OBJECTIVE
  To evaluate retinal sensitivity in patients with diabetic macular edema who received intravitreal aflibercept injection (IAI) or laser.
  
  
  METHODS
  A substudy included 46 patients from DA VINCI (a randomized, double-masked Phase 2 study) receiving either laser, 0.5 mg IAI every 4 weeks, 2 mg IAI every 4 weeks, 2 mg IAI every 8 weeks after 3 monthly doses (2q8), or 2 mg IAI as-needed after 3 monthly doses for 52 weeks. Retinal sensitivity was measured in one (central), five (one central and four inner), and eight (four inner and four outer) optical coherence tomography subfields.
  
  
  RESULTS
  Mean best-corrected visual acuity improvement in the subgroup at Week 52 was 3.3 letters with laser and ranged from 5.4 to 16.3 letters in the IAI groups. Retinal sensitivity of laser patients at Week 52 was comparable with baseline in the central optical coherence tomography subfield but decreased in the five and eight optical coherence tomography subfields. Compared with laser, retinal sensitivity significantly increased with IAI in the 2q8 and pooled IAI groups in the 5 and 8 optical coherence tomography subfields at Week 52 (P < 0.05).
  
  
  CONCLUSIONS
  Intravitreal aflibercept injection improved best-corrected visual acuity and retinal sensitivity in this subgroup of patients. Laser may cause a deterioration of macular function that is not detectable with best-corrected visual acuity testing.
authors.affiliation: *Valley Retina Institute, McAllen, Texas; †Retina-Vitreous Associates Medical Group, Beverly Hills, California; ‡Department of Ophthalmology, Medical University of Vienna, Vienna, Austria; §Ophthalmic Consultants of Boston and Tufts University School of Medicine, Boston, Massachusetts; ¶TLC EyeCare and Laser Center, Jackson, Michigan; **Retina Consultants of Houston, Houston, Texas; ††Southeast Retina Center, Augusta, Georgia; ‡‡Department of Ophthalmology, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri; §§Regeneron Pharmaceuticals, Inc, Tarrytown, New York; ¶¶Bayer Healthcare, Berlin, Germany; ***Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; †††Department of Neurology, Heinrich-Heine Universität, Düsseldorf, Germany; and ‡‡‡Department of Ophthalmology, Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska.
authors.forename: Victor H
authors.initials: VH
authors.lastname: Gonzalez
authors.forename: David S
authors.initials: DS
authors.lastname: Boyer
authors.forename: Ursula
authors.initials: U
authors.lastname: Schmidt-Erfurth
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Heier
authors.forename: Carmelina
authors.initials: C
authors.lastname: Gordon
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Benz
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Marcus
authors.forename: Nelson R
authors.initials: NR
authors.lastname: Sabates
authors.forename: Robert
authors.initials: R
authors.lastname: Vitti
authors.forename: Husain
authors.initials: H
authors.lastname: Kazmi
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: Berliner
authors.forename: Yuhwen
authors.initials: Y
authors.lastname: Soo
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Zhu
authors.forename: Hadi
authors.initials: H
authors.lastname: Moini
authors.forename: Oliver
authors.initials: O
authors.lastname: Zeitz
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
authors.forename: Diana V
authors.initials: DV
authors.lastname: Do
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D040262:Receptors, Vascular Endothelial Growth Factor / Q000009:adverse effects / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D012160:Retina / Q000502:physiology*; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000187:drug effects; D058609:Visual Field Tests; D014794:Visual Fields / 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