title: Vision-related function after ranibizumab treatment for diabetic macular edema: results from RIDE and RISE.
abstract: OBJECTIVE
  To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as assessed by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores, in patients with visual impairment secondary to center-involved diabetic macular edema (DME).
  
  
  METHODS
  Within 2 randomized, double-masked, phase 3 clinical trials (RIDE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473382] and RISE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473330]), the NEI VFQ-25 was administered at baseline and at the 6-, 12-, 18-, and 24-month follow-up visits.
  
  
  METHODS
  Three hundred eighty-two (100%) RIDE patients and 377 (100%) RISE patients.
  
  
  METHODS
  Patients were randomized 1:1:1 to monthly injections of intravitreal ranibizumab 0.3 or 0.5 mg or sham. Study participants could receive macular laser for DME from month 3 onward if specific criteria were met.
  
  
  METHODS
  Exploratory post hoc analysis of mean change from baseline in NEI VFQ-25 scores at 12 and 24 months.
  
  
  RESULTS
  Across all treatment arms, 13% to 28% of enrolled eyes were the better-seeing eye. For all eyes in RIDE and RISE, the mean change in NEI VFQ-25 composite score improved more in ranibizumab-treated eyes at both the 12- and 24-month visits compared with sham treatment. For the better-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 10.9 more (95% confidence interval [CI], 2.5-19.2) than sham for RIDE patients and 1.3 more (95% CI, -10.5 to 13.0) than sham for RISE patients. For the worse-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 1.0 more (95% CI, -4.7 to 6.7) than sham for RIDE patients and 1.8 more (95% CI, -2.7 to 6.2) than sham for RISE patients. Similar results for most of these outcomes were seen with 0.5 mg ranibizumab.
  
  
  CONCLUSIONS
  These phase 3 trials demonstrated that ranibizumab treatment for DME likely improves patient-reported vision-related function outcomes compared with sham, further supporting treatment of DME with ranibizumab.
authors.affiliation: Retina Division, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: nmboffice@jhmi.edu.
authors.forename: Neil M
authors.initials: NM
authors.lastname: Bressler
authors.affiliation: University of Southern California Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.
authors.forename: Rohit
authors.initials: R
authors.lastname: Varma
authors.affiliation: Retina Associates of Florida, Tampa, Florida.
authors.forename: Ivan J
authors.initials: IJ
authors.lastname: Suñer
authors.affiliation: Genentech, Inc., South San Francisco, California.
authors.forename: Chantal M
authors.initials: CM
authors.lastname: Dolan
authors.affiliation: Genentech, Inc., South San Francisco, California.
authors.forename: James
authors.initials: J
authors.lastname: Ward
authors.affiliation: Genentech, Inc., South San Francisco, California.
authors.forename: Jason S
authors.initials: JS
authors.lastname: Ehrlich
authors.affiliation: Genentech, Inc., South San Francisco, California.
authors.forename: Shoshana
authors.initials: S
authors.lastname: Colman
authors.affiliation: Genentech, Inc., South San Francisco, California.
authors.forename: Adam
authors.initials: A
authors.lastname: Turpcu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab