title: A randomised controlled trial of ranibizumab with and without ketorolac eyedrops for exudative age-related macular degeneration.
abstract: OBJECTIVE
  To evaluate whether ketorolac eyedrops and ranibizumab intravitreal injections would provide additional benefit over ranibizumab alone in the treatment of choroidal neovascularisation (CNV).
  
  
  METHODS
  This was a pilot study of eyes with new-onset CNV. A total of 56 patients were enrolled consecutively and randomised in a 1:1 ratio to receive combination treatment with intravitreal ranibizumab and topical ketorolac (group 1) or ranibizumab alone (group 2). All patients received monthly 0.5-mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered in accordance with the standard of care. Group 1 patients also self-administered one drop of ketorolac three times a day for 6 months. All patients were followed up for 6 months.
  
  
  RESULTS
  At 6 months, both groups showed a significant improvement in best-corrected visual acuity (both, p<0.001). The two treatments did not show significant differences in terms of the number of ranibizumab injections required. However, the mean 6-month change in central macular thickness (CMT) in the combination group was -124 µm (-29.7%; p<0.001), while in the ranibizumab-only group, the change was -86.9 µm (-19.5%; p=0.001); thus, the combination treatment resulted in a greater reduction (p=0.003). The combination treatment had no adverse effects.
  
  
  CONCLUSIONS
  This pilot study is the first to prospectively investigate the efficacy and safety of a combination of 0.45% ketorolac eyedrops three times a day and intravitreal ranibizumab injections in patients with CNV, and suggests that topical ketorolac supplements the activity of intravitreal ranibizumab in reducing CMT in CNV.
authors.affiliation: Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, , Brescia, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Russo
authors.forename: Ciro
authors.initials: C
authors.lastname: Costagliola
authors.forename: Luisa
authors.initials: L
authors.lastname: Delcassi
authors.forename: Mario R
authors.initials: MR
authors.lastname: Romano
authors.forename: Francesco
authors.initials: F
authors.lastname: Semeraro
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005122:Exudates and Transudates; D005260:Female; D006801:Humans; D020910:Ketorolac / Q000008:administration & dosage*; D008266:Macula Lutea / Q000473:pathology; D008268:Macular Degeneration / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage; 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; D009883:Ophthalmic Solutions; D020910:Ketorolac; D000069579:Ranibizumab
keywords: Inflammation; Retina