title: Head-to-head comparison of ranibizumab PRN versus single-dose dexamethasone for branch retinal vein occlusion (COMRADE-B).
abstract: OBJECTIVE
  To compare the efficacy and safety of ranibizumab 0.5 mg versus dexamethasone 0.7 mg according to their European labels in macular oedema secondary to branch retinal vein occlusion (BRVO) in a 6-month, phase IIIb, randomized trial.
  
  
  METHODS
  Patients received either monthly ranibizumab for 3 months followed by Pro re nata (PRN) treatment (n = 126) or a sustained-release dexamethasone implant followed by PRN sham injections (n = 118). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean changes in BCVA and foveal centre point thickness (FCPT), and adverse events (AEs).
  
  
  RESULTS
  There was no difference in BCVA gains between the treatments prior to month 3. Best-corrected visual acuity (BCVA) gain with dexamethasone declined thereafter. From month 3 to month 6, mean BCVA change from baseline was significantly higher with ranibizumab than with dexamethasone [raw means (standard deviation):+16.2 (±11) letters versus +9.3 (±10.1) letters]. At month 6, the difference in BCVA gains from baseline was +17.3 letters in the ranibizumab versus +9.2 letters in the dexamethasone group. Patients in the ranibizumab group received a mean of 2.94 loading injections and 1.74 PRN retreatment injections, while those in the dexamethasone group received a single loading injection. Elevated intraocular pressure (IOP) and AEs were more frequent with dexamethasone than ranibizumab treatment.
  
  
  CONCLUSIONS
  Ranibizumab PRN resulted in greater visual acuity (VA) gains in macular oedema following BRVO compared with single-dose dexamethasone over a 6-month study period, observed from month 3, when administered according to their European label. In clinical practice, retreatment with dexamethasone may be required prior to this point.
authors.affiliation: Department of Ophthalmology, Ludwigshafen Hospital, Ludwigshafen, Germany.
authors.forename: Lars-Olof
authors.initials: LO
authors.lastname: Hattenbach
authors.affiliation: Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Feltgen
authors.affiliation: Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany.|Novartis Pharma GmbH, Nuremberg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bertelmann
authors.affiliation: Department of Ophthalmology, GRADE Reading Center, University of Bonn, Bonn, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Schmitz-Valckenberg
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 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, University of Surrey, Guildford, UK.
authors.forename: Simon R
authors.initials: SR
authors.lastname: Taylor
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.
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: Department of Ophthalmology, Medizinische Hochschule Hannover, Hannover, Germany.
authors.forename: Amelie
authors.initials: A
authors.lastname: Pielen
authors.affiliation: Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany.
authors.forename: Hans
authors.initials: H
authors.lastname: Hoerauf
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005584:Fovea Centralis / Q000473:pathology; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage*; D012170:Retinal Vein Occlusion / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012189:Retrospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D005938:Glucocorticoids; D042461:Vascular Endothelial Growth Factor A; D003907:Dexamethasone; D000069579:Ranibizumab
keywords: 
  PRN
  ; branch retinal vein occlusion; dexamethasone; ranibizumab