title: Outcomes after a 1-Year Treatment with Ranibizumab for Diabetic Macular Edema in a Clinical Setting.
abstract: OBJECTIVE
  The aim of this study was to assess the efficacy and safety of ranibizumab in patients with diabetic macular edema (DME).
  
  
  METHODS
  We conducted a retrospective analysis of consecutive patients with vision loss due to DME who were treated with ranibizumab. All patients received a loading dose of 3 monthly injections followed by re-treatments on an as-needed basis. The primary endpoint was the change in best-corrected visual acuity (BCVA) at 12 months. Secondary endpoints were the change in central retinal thickness (CRT) and the number of intravitreal injections (IVI) at 12 months.
  
  
  RESULTS
  One hundred and six eyes of 78 patients were included. BCVA changed from 48.3 (20/100) letters at baseline to 59.0 letters (20/63) at 12 months (p < 0.0001; mean gain: +10.7 letters), and 38% of the patients had a final BCVA >70 letters. CRT decreased from 519 µm at baseline to 355 µm at 12 months (p < 0.0001). The threshold of the first quartile of the baseline VA was 40 letters. Patients with a baseline VA >40 letters had a higher final VA of 66 ± 14 letters (20/50) versus 43 ± 18 letters (20/125) for patients with a baseline VA ≤40 letters (p < 0.0001). A mean number of 5.4 (3-10) IVI were administered.
  
  
  CONCLUSIONS
  This study conducted in a clinical setting confirms the results of previous randomized trials. The final BCVA was mainly influenced by the baseline BCVA, which supports the utility of early DME treatment before patients experience a severe vision loss.
authors.affiliation: Ophthalmology Department, Avicenne Hospital, Bobigny, France.
authors.forename: Linda
authors.initials: L
authors.lastname: Hrarat
authors.forename: Franck
authors.initials: F
authors.lastname: Fajnkuchen
authors.forename: Marouane
authors.initials: M
authors.lastname: Boubaya
authors.forename: Vincent
authors.initials: V
authors.lastname: Lévy
authors.forename: Valérie
authors.initials: V
authors.lastname: Sarda
authors.forename: Typhaine
authors.initials: T
authors.lastname: Grenet
authors.forename: Sylvia
authors.initials: S
authors.lastname: Nghiem-Buffet
authors.forename: Gilles
authors.initials: G
authors.lastname: Chaine
authors.forename: Audrey
authors.initials: A
authors.lastname: Giocanti-Auregan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D003930:Diabetic Retinopathy / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage*; D012160:Retina / Q000000981:diagnostic imaging*; D012189:Retrospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D000069579:Ranibizumab