title: Intravitreal Aflibercept Injection in Eyes With Substantial Vision Loss After Laser Photocoagulation for Diabetic Macular Edema: Subanalysis of the VISTA and VIVID Randomized Clinical Trials.
abstract: OBJECTIVE
  Information on the effect of anti-vascular endothelial growth factor therapy in eyes with diabetic macular edema (DME) with vision loss after macular laser photocoagulation is clinically valuable.
  
  
  OBJECTIVE
  To evaluate visual and anatomic outcomes in a subgroup of macular laser photocoagulation treatment control (hereafter laser control) eyes with substantial vision loss receiving treatment with intravitreal aflibercept injection.
  
  
  METHODS
  This investigation was a post hoc analysis of a subgroup of laser control eyes in 2 phase 3 trials-VISTA (Study of Intravitreal Aflibercept Injection in Patients With Diabetic Macular Edema) and VIVID (Intravitreal Aflibercept Injection in Vision Impairment Due to DME)-in a multicenter setting. One hundred nine laser control eyes with center-involving DME were included.
  
  
  METHODS
  Treatment with intravitreal aflibercept injection (2 mg) every 8 weeks after 5 monthly doses with sham injections on nontreatment visits starting at week 24 was initiated on meeting prespecified criteria of at least a 10-letter visual acuity loss at 2 consecutive visits or at least a 15-letter visual acuity loss from the best previous measurement at 1 visit and vision not better than at baseline.
  
  
  METHODS
  Visual and anatomic outcomes in a subgroup of laser control eyes receiving treatment with intravitreal aflibercept injection.
  
  
  RESULTS
  Through week 100, a total of 63 of 154 eyes (40.9%) in VISTA and 46 of 133 eyes (34.6%) in VIVID initially randomized to laser control received treatment with intravitreal aflibercept injection. The median time from week 24 to the first intravitreal aflibercept injection treatment was 34.0 (VISTA) and 83.5 (VIVID) days. In this subgroup, the mean (SD) visual gain from baseline to week 100 was 2.2 (12.5) (VISTA) and 3.8 (10.1) (VIVID) letters. At the time of intravitreal aflibercept injection initiation, these eyes had a mean (SD) loss of 11.0 (10.1) (VISTA) and 10.0 (6.5) (VIVID) letters from baseline, and they subsequently gained a mean (SD) of 17.4 (9.7) (VISTA) and 13.6 (8.6) (VIVID) letters from the initiation of treatment with intravitreal aflibercept injection through week 100. There was a minimal mean change in central subfield thickness from baseline in these eyes at the time of intravitreal aflibercept injection initiation (an increase of 3.9 μm in VISTA and a decrease of 3.0 μm in VIVID), after which further mean (SD) reductions of 285.6 (202.6) μm (VISTA) and 313.4 (181.9) μm (VIVID) occurred through week 100.
  
  
  CONCLUSIONS
  Intravitreal aflibercept injection improves visual and anatomic outcomes in eyes experiencing substantial vision loss after macular laser photocoagulation treatment for DME.
  
  
  BACKGROUND
  clinicaltrials.gov Identifiers: NCT01363440 and NCT01331681.
authors.affiliation: Retina Consultants of Houston, Houston, Texas.
authors.forename: Charles C
authors.initials: CC
authors.lastname: Wykoff
authors.affiliation: Southeast Retina Center, Augusta, Georgia.
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Marcus
authors.affiliation: Department of Ophthalmology, University of Padova, Padova, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Midena
authors.affiliation: Service d'Ophtalmologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France5University Bordeaux, Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Bordeaux, France6Institut National de la Santé et de la Récherche Médicale Unité 1219, Bordeaux Population Health Research Center, Bordeaux, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Korobelnik
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Namrata
authors.initials: N
authors.lastname: Saroj
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Andrea
authors.initials: A
authors.lastname: Gibson
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: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Zinaria
authors.initials: Z
authors.lastname: Williams Liu
authors.affiliation: Bayer HealthCare Pharmaceuticals, Berlin, Germany9University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Zeitz
authors.affiliation: Bayer HealthCare Pharmaceuticals, Berlin, Germany.
authors.forename: Carola
authors.initials: C
authors.lastname: Metzig
authors.affiliation: Bayer HealthCare Pharmaceuticals, Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmelter
authors.affiliation: Ophthalmic Consultants of Boston, Boston, Massachusetts.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Heier