title: Comparing the Effectiveness of Bevacizumab to Ranibizumab in Patients with Exudative Age-Related Macular Degeneration. The BRAMD Study.
abstract: To compare the effectiveness of bevacizumab and ranibizumab in the treatment of exudative age-related macular degeneration (AMD).
  
  
  
  Multicentre, randomized, controlled, double-masked clinical trial in 327 patients. The non-inferiority margin was 4 letters.
  
  
  
  Patients ≥ 60 years of age with primary or recurrent sub- or juxtafoveal choroidal neovascularization (CNV) secondary to AMD with a total area of CNV < 12 disc areas and a best corrected visual acuity (BCVA) score between 20 and 78 letters on an EDTRS like chart in the study eye.
  
  
  
  Monthly intravitreal injections with 1.25 mg bevacizumab or 0.5 mg ranibizumab were given during one year. Intention to treat with last observation carried forward analysis was performed.
  
  
  
  Primary outcome was the change in BCVA in the study eye from baseline to 12 months.
  
  
  
  The mean gain in BCVA was 5.1 (±14.1) letters in the bevacizumab group (n = 161) and 6.4 (±12.2) letters in the ranibizumab group (n = 166) (p = 0.37). The lower limit of the 95% confidence interval of the difference in BCVA gain was 3.72. The response to bevacizumab was more varied; 24% of patients showed a gain of ≥15 letters, 11% a loss of ≥15 letters and 65% a gain or loss < 15 letters compared to 19%, 5% and 76% respectively for ranibizumab (p = 0.038). No significant differences in absolute CRT and CRT change (p = 0.13) or in the presence of subretinal or intraretinal fluid (p = 0.14 and 0.10, respectively) were observed. However, the presence of any fluid on SD-OCT (subretinal and/or intraretinal) differed significantly (p = 0.020), with definite fluid on SD-OCT in 45% of the patients for bevacizumab versus 31% for ranibizumab. The occurrence of serious adverse events and adverse events was similar, with 34 SAEs and 256 AEs in the bevacizumab group and 37 SAEs and 299 AEs in the ranibizumab group (p = 0.87 and p = 0.48, respectively).
  
  
  
  Bevacizumab was not inferior to ranibizumab. The response to bevacizumab was more varied with higher percentages of both gainers and losers and more frequently observed retinal fluid on SD-OCT at 12 months when compared to the ranibizumab group.
  
  
  
  Trialregister.nl NTR1704.
authors.affiliation: Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: A M E
authors.identifier: 0000-0002-0020-4842
authors.initials: AM
authors.lastname: Schauwvlieghe
authors.affiliation: Department of Ophthalmology, Leiden University Medical Centre, Leiden, the Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Dijkman
authors.affiliation: Department of Ophthalmology, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: J M
authors.initials: JM
authors.lastname: Hooymans
authors.affiliation: Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.|Ocular Angiogenesis Group, Departments of Ophthalmology and Cell Biology and Histology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.|Department of Biomedical Engineering and Physics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: F D
authors.initials: FD
authors.lastname: Verbraak
authors.affiliation: Department of Ophthalmology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors.forename: C B
authors.initials: CB
authors.lastname: Hoyng
authors.affiliation: Clinical Research Unit, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: M G W
authors.initials: MG
authors.lastname: Dijkgraaf
authors.affiliation: National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology, Reading Centre, Moorfields Eye Hospital, London, the United Kingdom.
authors.forename: T
authors.initials: T
authors.lastname: Peto
authors.affiliation: Department of Ophthalmology, Erasmus Medical Center, Rotterdam, The Netherlands.|Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: J R
authors.initials: JR
authors.lastname: Vingerling
authors.affiliation: Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.|Ocular Angiogenesis Group, Departments of Ophthalmology and Cell Biology and Histology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.|Netherlands Institute for Neurosciences, Amsterdam, The Netherlands.
authors.forename: R O
authors.initials: RO
authors.lastname: Schlingemann
mesh_terms: D000368:Aged; D000068258:Bevacizumab / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014792:Visual Acuity; D014822:Vitreous Body; D057135:Wet Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D000068258:Bevacizumab; D000069579:Ranibizumab