title: Efficacy and safety of a fixed bimonthly ranibizumab treatment regimen in eyes with neovascular age-related macular degeneration: results from the RABIMO trial.
abstract: OBJECTIVE
  To evaluate prospectively the efficacy and safety of a fixed bimonthly ranibizumab treatment regimen (RABIMO) in eyes with neovascular age-related macular degeneration (nAMD) and to compare these results with a pro re nata (PRN) treatment scheme.
  
  
  METHODS
  This was a 12-month, phase IV, single center, randomised, non-inferiority study. Following three initial monthly injections, patients were randomised to receive either ranibizumab bimonthly (RABIMO group) or ranibizumab PRN (PRN group) (n = 20 each). Main outcome measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), number of injections, and adverse events (AEs).
  
  
  RESULTS
  BCVA [median (interquartile range, IQR)] increased significantly in both groups after 12 months [RABIMO group +8.5 (14); PRN group +6.5 (16) ETDRS letters] when compared to baseline (p < 0.0001; p = 0.0085). At month 12, the RABIMO treatment regimen was non-inferior to the PRN scheme (∆BCVA = 3.5 ETDRS letters; p < 0.0001). CRT was significantly reduced in both groups after the 12-month study period (p < 0.0001 each), with no significant difference between groups (p = 0.6772). Number of overall injections [median (IQR)] was 8 (0) in the RABIMO versus 4 (5) in the PRN group (p = 0.0037). Three patients in the RABIMO group received one additional unscheduled injection. We observed no significant differences between groups in the number of patients with reported SAEs/AEs (RABIMO group n = 6/15; PRN group n = 7/13) (p = 0.7357/p = 0.4902).
  
  
  CONCLUSIONS
  We found no evidence of significant functional or anatomical differences between the RABIMO and PRN treatment regimens. However, the RABIMO group's number of injections was twice as high as the PRN group's (protocol-driven). In light of potential side effects, the fixed bimonthly treatment regimen might not be advisable for routine clinical care, but it might be a worthwhile treatment option if monthly monitoring is not possible. Eudra-CT number: 2009-017324-11.
authors.affiliation: Department of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany. nicolas.feltgen@med.uni-goettingen.de.
authors.forename: Nicolas
authors.identifier: http://orcid.org/0000-0002-6857-3003
authors.initials: N
authors.lastname: Feltgen
authors.affiliation: Department of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bertelmann
authors.affiliation: Department of Ophthalmology, Carl-Thiem-Klinikum gGmbH, Cottbus, Germany.
authors.forename: Mirko
authors.initials: M
authors.lastname: Bretag
authors.affiliation: Institute for Clinical Research GmbH, Georg-August-University, Goettingen, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Pfeiffer
authors.affiliation: Institute for Medical Statistics, Georg-August-University, Goettingen, Germany.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Hilgers
authors.affiliation: Department of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
authors.forename: Josep
authors.initials: J
authors.lastname: Callizo
authors.affiliation: Eye Centre Celle, Celle, Germany.
authors.forename: Lena
authors.initials: L
authors.lastname: Goldammer
authors.affiliation: Department of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Bemme
authors.affiliation: Department of Ophthalmology, University Medical Centre, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
authors.forename: Hans
authors.initials: H
authors.lastname: Hoerauf
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008266:Macula Lutea / Q000473:pathology*; D008297:Male; D011446:Prospective Studies; D000069579:Ranibizumab / Q000008:administration & dosage*; D013997:Time Factors; D041623:Tomography, Optical Coherence / Q000379:methods*; D016896:Treatment Outcome; D014792:Visual Acuity; D057135:Wet Macular Degeneration / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D020533:Angiogenesis Inhibitors; D000069579:Ranibizumab
keywords: AMD; Age-related macular degeneration; Optical coherence tomography; PRN; Ranibizumab; Treatment schedule