title: Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: randomized clinical trial.
abstract: OBJECTIVE
  Few data are available on relative changes in vision-related function after treatment for diabetic macular edema (DME).
  
  
  OBJECTIVE
  To determine the impact of intravitreal ranibizumab, 0.5 mg, compared with laser on patient-reported visual function.
  
  
  METHODS
  Phase 3, randomized, double-masked, 12-month study (RESTORE).
  
  
  METHODS
  Outpatient retina practices in Australia, Canada, and Europe.
  
  
  METHODS
  Patients 18 years or older with type 1 or 2 diabetes mellitus and visual impairment due to DME.
  
  
  METHODS
  Patients were randomized to ranibizumab plus sham laser (n = 116), ranibizumab plus laser (n = 118), or sham injections plus laser (n = 111). Ranibizumab and sham injections were given for 3 consecutive months then as needed; laser or sham laser treatment was given at baseline then as needed.
  
  
  METHODS
  National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) scores at 0, 3, and 12 months for patients receiving 1 or more study treatments with 1 or more postbaseline NEI VFQ-25 assessments and last observation carried forward for missing data.
  
  
  RESULTS
  Mean baseline NEI VFQ-25 composite scores were 72.8, 73.5, and 74.1 in the ranibizumab, laser, and ranibizumab plus laser groups, respectively. At 12 months, the mean composite scores (95% CIs) improved by 5.0 (ranibizumab vs laser, 2.6 to 7.4; P = .01 vs laser) and 5.4 (ranibizumab plus laser vs laser alone, 3.3 to 7.4; P = .004 vs laser) from baseline in the ranibizumab and ranibizumab plus laser groups, respectively, compared with 0.6 (-1.8 to 3.0) for the laser group. Near activities scores improved by 9.0 (ranibizumab vs laser, 5.0 to 13.0; P = .01) and 9.1 (ranibizumab plus laser vs laser, 5.6 to 12.6; P = .006) compared with 1.1 (-3.0 to 5.2) for the laser group, whereas distance activities scores improved by 5.3 (ranibizumab vs laser, 1.8 to 8.9; P = .04) and 5.6 (ranibizumab plus laser vs laser, 2.3 to 9.0; P = .03) compared with 0.4 (-3.1 to 3.8) for the laser group. Patients with better baseline visual acuity or lower central retinal thickness had greater improvements with ranibizumab treatment compared with laser in composite and some subscale scores compared with patients with worse visual acuity or higher central retinal thickness.
  
  
  CONCLUSIONS
  These data provide vision-related, patient-reported outcome evidence that mirrors visual acuity outcomes and supports benefits from ranibizumab or ranibizumab plus laser treatment for patients with DME and characteristics similar to those enrolled in this randomized clinical trial.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00687804.
authors: Department of Ophthalmology, University of Sydney, Sydney, Australia.
authors: Paul
authors: P
authors: Mitchell
authors: Neil
authors: N
authors: Bressler
authors: Keith
authors: K
authors: Tolley
authors: Meghan
authors: M
authors: Gallagher
authors: Jennifer
authors: J
authors: Petrillo
authors: Alberto
authors: A
authors: Ferreira
authors: Robert
authors: R
authors: Wood
authors: Francesco
authors: F
authors: Bandello
mesh_terms: D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; 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; D000069579:Ranibizumab; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014786:Vision Disorders / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity / Q000502:physiology*; D019987:Persons with Visual Disabilities
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab