title: Twenty-four-Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes - Protocol 3 with High Dose (READ-3) Study.
abstract: To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME).
  
  
  
  Randomized, controlled, double-masked (to the dose), interventional, multicenter clinical trial.
  
  
  
  A total of 152 patients (152 eyes) with DME.
  
  
  
  Eligible eyes were randomized in a 1:1 ratio to 0.5 mg (n = 77) or 2.0 mg (n = 75) RBZ. Study eyes received 6 monthly mandatory injections followed by as-needed injections until month 24.
  
  
  
  The primary efficacy end point of the study was mean change in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) at month 6. Secondary outcomes included the mean change in BCVA and CFT at month 24, and incidence and severity of systemic and ocular adverse events through month 24.
  
  
  
  A total of 152 eyes were randomized in the study. At month 24, the mean improvement from baseline BCVA was +11.06 letters in the 0.5 mg RBZ group (n = 59) and +6.78 letters in the 2.0 mg RBZ group (n = 54) (P = 0.02). The mean numbers of RBZ injections through month 24 were 18.4 and 17.3 in the 0.5 mg and 2.0 mg RBZ groups, respectively (P = 0.08). The mean change in CFT was -192.53 μm in the 0.5 mg RBZ group and -170.64 μm in the 2.0 mg RBZ group (P = 0.41). By month 24, 3 deaths had occurred in the 0.5 mg RBZ group and 3 deaths had occurred in the 2.0 mg RBZ group; 5 of these 6 deaths occurred secondary to cardiovascular causes, and 1 death occurred as the result of severe pneumonia. All 5 patients with a cardiovascular cause of death had a history of coronary heart disease.
  
  
  
  At month 24, there were significant visual and anatomic improvements in both groups, with subjects in the 0.5 mg RBZ group gaining more vision. Visual and anatomic gains achieved at month 6 were largely maintained through month 24. No new safety events were identified. In this study population, 2.0 mg RBZ does not appear to provide additional benefit over 0.5 mg RBZ.
authors.affiliation: Ocular Imaging Research and Reading Center, Omaha, Nebraska.
authors.forename: Yasir J
authors.initials: YJ
authors.lastname: Sepah
authors.affiliation: Ocular Imaging Research and Reading Center, Omaha, Nebraska.
authors.forename: Mohammad Ali
authors.initials: MA
authors.lastname: Sadiq
authors.affiliation: Retina Vitreous Associates, Beverly Hills, California.
authors.forename: David
authors.initials: D
authors.lastname: Boyer
authors.affiliation: Texas Retina Associates, Arlington, Texas.
authors.forename: David
authors.initials: D
authors.lastname: Callanan
authors.affiliation: Retina Macula Institute, Torrance, California.
authors.forename: Ron
authors.initials: R
authors.lastname: Gallemore
authors.affiliation: Retina Institute of Hawaii, Honolulu, Hawaii.
authors.forename: Michael
authors.initials: M
authors.lastname: Bennett
authors.affiliation: Southeast Retina Center, Augusta, Georgia.
authors.forename: Dennis
authors.initials: D
authors.lastname: Marcus
authors.affiliation: Retina Group of Florida, Fort Lauderdale, Florida.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Halperin
authors.affiliation: Ocular Imaging Research and Reading Center, Omaha, Nebraska.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Hassan
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Campochiaro
authors.affiliation: Ocular Imaging Research and Reading Center, Omaha, Nebraska.
authors.forename: Quan Dong
authors.initials: QD
authors.lastname: Nguyen
authors.affiliation: Ocular Imaging Research and Reading Center, Omaha, Nebraska. Electronic address: diana.do@unmc.edu.
authors.forename: Diana V
authors.initials: DV
authors.lastname: Do
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008266:Macula Lutea / Q000187:drug effects; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage* / Q000009:adverse effects; D019233:Retreatment; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000187:drug effects / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab