title: Efficacy/safety of ranibizumab monotherapy or with laser versus laser monotherapy in DME.
abstract: OBJECTIVE
  To compare the efficacy and safety of ranibizumab 0.5 mg intravitreal injection, as monotherapy or in combination with laser, with laser monotherapy in patients with visual impairment caused by diabetic macular edema.
  
  
  METHODS
  Twelve-month, multicentre, open-label, parallel-group, randomized, active-control study.
  
  
  METHODS
  A total of 220 (ranibizumab monotherapy: n = 75, ranibizumab + laser: n = 73, laser monotherapy: n = 72) patients with a diagnosis of type I or II diabetes and visual impairment caused by macular edema were included in the efficacy analysis.
  
  
  METHODS
  Ranibizumab was initiated with a fixed loading phase of 3 monthly injections followed by as needed therapy until stable vision achievement. Efficacy end points were the change in best corrected visual acuity (BCVA), change in central retinal thickness (CRT) measured by optical coherence tomography, proportion achieving a 15-letter BCVA gain, and 12-month Visual Function Questionnaire-25 (VFQ-25) score. Safety was assessed with the incidence and severity of adverse events.
  
  
  RESULTS
  At 12 months, significant (p < 0.001) mean BCVA improvements were observed for both the ranibizumab monotherapy (+8.9 [95% confidence interval (CI) 7.0-10.7] letters) and the ranibizumab + laser (+8.2 [95% CI 6.0-10.4] letters) groups compared with the laser monotherapy group (+0.3 [95% CI -2.9 to 3.5] letters). Similarly, a better response in terms of CRT improvement, BCVA letter gain, and VFQ-25 was observed in both ranibizumab groups compared with laser monotherapy. The safety profile was comparable in the 2 ranibizumab groups.
  
  
  CONCLUSIONS
  Ranibizumab as monotherapy or combined with laser resulted in significantly higher improvements in visual acuity and vision-related quality of life at month 12 as compared with laser monotherapy.
authors.affiliation: St. Michael's Hospital, Toronto.
authors.forename: Alan
authors.initials: A
authors.lastname: Berger
authors.affiliation: Ivey Eye Institute, St. Joseph's Hospital, London, Ont. Electronic address: Sheidowt@me.com.
authors.forename: Tom
authors.initials: T
authors.lastname: Sheidow
authors.affiliation: Dalhousie University, Halifax, N.S.
authors.forename: Alan F
authors.initials: AF
authors.lastname: Cruess
authors.affiliation: CHUM, Notre-Dame Hospital & University of Montreal, Montreal.
authors.forename: Jean Daniel
authors.initials: JD
authors.lastname: Arbour
authors.affiliation: Novartis Pharmaceuticals, Dorval, Que.
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Courseau
authors.affiliation: Novartis Pharmaceuticals, Dorval, Que.
authors.forename: Frederica
authors.initials: F
authors.lastname: de Takacsy
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003930:Diabetic Retinopathy / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation / Q000379:methods*; D008269:Macular Edema / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D000069579:Ranibizumab / Q000009:adverse effects / Q000627:therapeutic use*; D012160:Retina / Q000473:pathology; 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; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab