title: Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose).
abstract: OBJECTIVE
  To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME) and a central subfield thickness (CFT) of ≥250 μm on time-domain optical coherence tomography.DesignRandomized, controlled, multicenter clinical trial.
  
  
  METHODS
  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 injections.Main outcome measuresThe primary outcome measure was the mean change in best corrected visual acuity (BCVA) at month 6. Secondary outcomes included the incidence and severity of systemic and ocular adverse events and the mean change in CFT from baseline.
  
  
  RESULTS
  In all, 152 eyes (152 patients) were randomized in the study. At month 6, the mean improvement from baseline BCVA was +9.43 letters in the 0.5 mg RBZ group and +7.01 letters in the 2.0 mg RBZ group (P=0.161). At month 6, one death occurred in the 0.5 mg RBZ group and three deaths in the 2.0 mg RBZ group, all due to myocardial infarction in subjects with a prior history of heart disease. Mean CFT was reduced by 168.58 μm in the 0.5 mg RBZ group and by 159.70 μm in the 2.0 mg RBZ group (P=0.708).
  
  
  CONCLUSIONS
  There was no statistically significant difference in the mean number of letters gained between the 0.5 and 2.0 mg RBZ groups through month 6. In this DME study population, high-dose RBZ does not appear to provide additional benefit over 0.5 mg RBZ.
authors.affiliation: Stanley M. Truhlsen Eye Institute, Carl Camras Center for Innovative Clinical Research, University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: D V
authors.initials: DV
authors.lastname: Do
authors.affiliation: Stanley M. Truhlsen Eye Institute, Carl Camras Center for Innovative Clinical Research, University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: Y J
authors.initials: YJ
authors.lastname: Sepah
authors.affiliation: Retina Vitreous Associates, Beverly Hills, CA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Boyer
authors.affiliation: Texas Retina Associates, Arlington, TX, USA.
authors.forename: D
authors.initials: D
authors.lastname: Callanan
authors.affiliation: Retina Macula Institute, Torrance, CA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Gallemore
authors.affiliation: Retina Institute of Hawaii, Honolulu, HI, USA.
authors.forename: M
authors.initials: M
authors.lastname: Bennett
authors.affiliation: Southeast Retina Center, Augusta, GA, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Marcus
authors.affiliation: Retina Group of Florida, Fort Lauderdale, FL, USA.
authors.forename: L
authors.identifier: http://orcid.org/0000-0002-7959-2306
authors.initials: L
authors.lastname: Halperin
authors.affiliation: Stanley M. Truhlsen Eye Institute, Carl Camras Center for Innovative Clinical Research, University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: M A
authors.initials: MA
authors.lastname: Sadiq
authors.affiliation: Stanley M. Truhlsen Eye Institute, Carl Camras Center for Innovative Clinical Research, University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: N
authors.initials: N
authors.lastname: Rajagopalan
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: P A
authors.initials: PA
authors.lastname: Campochiaro
authors.affiliation: Stanley M. Truhlsen Eye Institute, Carl Camras Center for Innovative Clinical Research, University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: Q D
authors.initials: QD
authors.lastname: Nguyen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage*; D012160:Retina / Q000473:pathology; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors
chemical_list: D020533:Angiogenesis Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab