title: Prospective randomized controlled trial of combination ranibizumab (Lucentis) and bromfenac (Xibrom) for neovascular age-related macular degeneration: a pilot study.
abstract: OBJECTIVE
  To evaluate whether bromfenac eyedrops and ranibizumab intravitreal injections would provide added efficacy over ranibizumab alone.
  
  
  METHODS
  This was a single-site, multiinvestigator, prospective, open-label, interventional, Phase II study of patients with new or recurrent exudative/neovascular age-related macular degeneration. Thirty eyes were enrolled consecutively and were randomized in a ratio of 2:1 to combination therapy with intravitreal ranibizumab and topical bromfenac, and ranibizumab alone. All patients received ranibizumab monthly therapy for 4 months then as needed monthly in accordance with standard of care. Patients receiving bromfenac self-administered 1 drop twice a day for 12 months. Patients were followed for 12 months.
  
  
  RESULTS
  There were no safety concerns with the combination therapy. No statistically significant differences were identified in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity or the number of injections required. However, the mean 12-month change in central macular thickness in the combination group was -81.56 μm while in the ranibizumab group alone the change was -42.50 μm (P = 0.03). The proportion of eyes experiencing a decrease in CMT of 50 μm or more was also significantly higher in those receiving combination therapy (P = 0.046).
  
  
  CONCLUSIONS
  This pilot study is the first to prospectively identify a biologic signal that may indicate combination therapy with an easily administered well-tolerated eyedrop and ranibizumab is efficacious for the treatment of neovascular age-related macular degeneration. Further studies are warranted to validate this finding.
authors.affiliation: Macular Degeneration Center, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon 97239-4197, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Flaxel
authors.forename: Mitchell B
authors.initials: MB
authors.lastname: Schain
authors.forename: Sara C
authors.initials: SC
authors.lastname: Hamon
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Francis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001577:Benzophenones / Q000627:therapeutic use*; D001969:Bromobenzenes / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008268:Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use; D010865:Pilot Projects; D011446:Prospective Studies; D000069579:Ranibizumab; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D000894:Anti-Inflammatory Agents, Non-Steroidal; D061067:Antibodies, Monoclonal, Humanized; D001577:Benzophenones; D001969:Bromobenzenes; D009883:Ophthalmic Solutions; C053083:bromfenac; D000069579:Ranibizumab