title: Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study.
abstract: OBJECTIVE
  To compare the efficacy and safety of the European labels of ranibizumab 0.5 mg vs dexamethasone 0.7 mg in patients with macular edema secondary to central retinal vein occlusion (CRVO).
  
  
  METHODS
  Phase IIIb, multicenter, double-masked, randomized clinical trial.
  
  
  METHODS
  Patients were randomized (1:1) to receive either monthly ranibizumab followed by pro re nata (PRN) treatment (n = 124) or 1 sustained-release dexamethasone implant followed by PRN sham injections (n = 119). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean change in BCVA, and adverse events (AEs).
  
  
  RESULTS
  Of 243 patients, 185 (76.1%) completed the study. No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2. From month 3 to month 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs 2.96 letters; difference 9.91 letters, 95% confidence interval [6.51-13.30]; P < .0001). Mean injection number of ranibizumab was 4.52. Ocular AEs were reported in more patients in the dexamethasone than in the ranibizumab group (86.6% vs 55.6%).
  
  
  CONCLUSIONS
  Using the European labels, similar efficacy was observed for ranibizumab and dexamethasone at months 1 and 2. However, ranibizumab maintained its efficacy throughout the study, whereas dexamethasone declined from month 3 onward. The main limitation of the study was that dexamethasone patients received only a single treatment during the 6-month study. In clinical practice, dexamethasone retreatment may be required earlier than 6 months. Safety findings were similar to those previously reported.
authors.affiliation: Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany. Electronic address: hanshoerauf@yahoo.com.
authors.forename: Hans
authors.initials: H
authors.lastname: Hoerauf
authors.affiliation: Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Feltgen
authors.affiliation: Novartis Pharma GmbH, Nuremberg, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Weiss
authors.affiliation: Novartis Pharma GmbH, Nuremberg, Germany.
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Paulus
authors.affiliation: GRADE Reading Center, Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Schmitz-Valckenberg
authors.affiliation: University Eye Hospital, Universitätsklinikum Freiburg, Freiburg, Germany.
authors.forename: Amelie
authors.initials: A
authors.lastname: Pielen
authors.affiliation: Department of Ophthalmology, Royal Derby Hospital, Derby, United Kingdom.
authors.forename: Pankaj
authors.initials: P
authors.lastname: Puri
authors.affiliation: Department of Ophthalmology, St. Elisabeth-Hospital, Koeln-Hohenlind, Germany.
authors.forename: Hüsnü
authors.initials: H
authors.lastname: Berk
authors.affiliation: Department of Ophthalmology, University of Münster Medical Center, Münster, Germany.
authors.forename: Nicole
authors.initials: N
authors.lastname: Eter
authors.affiliation: Department of Ophthalmology, University of Leipzig, Leipzig, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Wiedemann
authors.affiliation: Department of Ophthalmology, University of Ulm, Ulm, Germany.
authors.forename: Gabriele E
authors.initials: GE
authors.lastname: Lang
authors.affiliation: Department of Ophthalmology, University of Leipzig, Leipzig, Germany; Department of Ophthalmology, Charité - Universitätsmedizin, Berlin, Germany.
authors.forename: Matus
authors.initials: M
authors.lastname: Rehak
authors.affiliation: Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany.
authors.forename: Armin
authors.initials: A
authors.lastname: Wolf
authors.affiliation: Novartis Pharma GmbH, Nuremberg, Germany; Department of Ophthalmology, Philipps-University Marburg, Marburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bertelmann
authors.affiliation: Department of Ophthalmology, Ludwigshafen Hospital, Ludwigshafen, Germany.
authors.forename: Lars-Olof
authors.initials: LO
authors.lastname: Hattenbach
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004343:Drug Implants; D005060:Europe; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006304:Health Status; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D000069579:Ranibizumab / Q000009:adverse effects / Q000627:therapeutic use*; D012170:Retinal Vein Occlusion / Q000188:drug therapy* / Q000503:physiopathology; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D004343:Drug Implants; D005938:Glucocorticoids; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D003907:Dexamethasone; D000069579:Ranibizumab