PMID- 28102456
OWN - NLM
STAT- MEDLINE
DCOM- 20170905
LR  - 20181113
IS  - 1435-702X (Electronic)
IS  - 0721-832X (Linking)
VI  - 255
IP  - 5
DP  - 2017 May
TI  - Efficacy and safety of a fixed bimonthly ranibizumab treatment regimen in eyes 
      with neovascular age-related macular degeneration: results from the RABIMO trial.
PG  - 923-934
LID - 10.1007/s00417-017-3589-x [doi]
AB  - PURPOSE: 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.
FAU - Feltgen, Nicolas
AU  - Feltgen N
AUID- ORCID: 0000-0002-6857-3003
AD  - Department of Ophthalmology, University Medical Centre, Robert-Koch-Strasse 40, 
      37075, Goettingen, Germany. nicolas.feltgen@med.uni-goettingen.de.
FAU - Bertelmann, Thomas
AU  - Bertelmann T
AD  - Department of Ophthalmology, University Medical Centre, Robert-Koch-Strasse 40, 
      37075, Goettingen, Germany.
FAU - Bretag, Mirko
AU  - Bretag M
AD  - Department of Ophthalmology, Carl-Thiem-Klinikum gGmbH, Cottbus, Germany.
FAU - Pfeiffer, Sebastian
AU  - Pfeiffer S
AD  - Institute for Clinical Research GmbH, Georg-August-University, Goettingen, 
      Germany.
FAU - Hilgers, Reinhard
AU  - Hilgers R
AD  - Institute for Medical Statistics, Georg-August-University, Goettingen, Germany.
FAU - Callizo, Josep
AU  - Callizo J
AD  - Department of Ophthalmology, University Medical Centre, Robert-Koch-Strasse 40, 
      37075, Goettingen, Germany.
FAU - Goldammer, Lena
AU  - Goldammer L
AD  - Eye Centre Celle, Celle, Germany.
FAU - Bemme, Sebastian
AU  - Bemme S
AD  - Department of Ophthalmology, University Medical Centre, Robert-Koch-Strasse 40, 
      37075, Goettingen, Germany.
FAU - Hoerauf, Hans
AU  - Hoerauf H
AD  - Department of Ophthalmology, University Medical Centre, Robert-Koch-Strasse 40, 
      37075, Goettingen, Germany.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170119
PL  - Germany
TA  - Graefes Arch Clin Exp Ophthalmol
JT  - Graefe's archive for clinical and experimental ophthalmology = Albrecht von 
      Graefes Archiv fur klinische und experimentelle Ophthalmologie
JID - 8205248
RN  - 0 (Angiogenesis Inhibitors)
RN  - ZL1R02VT79 (Ranibizumab)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/administration & dosage
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Intravitreal Injections
MH  - Macula Lutea/*pathology
MH  - Male
MH  - Prospective Studies
MH  - Ranibizumab/*administration & dosage
MH  - Time Factors
MH  - Tomography, Optical Coherence/*methods
MH  - Treatment Outcome
MH  - *Visual Acuity
MH  - Wet Macular Degeneration/diagnosis/*drug therapy/physiopathology
OTO - NOTNLM
OT  - AMD
OT  - Age-related macular degeneration
OT  - Optical coherence tomography
OT  - PRN
OT  - Ranibizumab
OT  - Treatment schedule
EDAT- 2017/01/20 06:00
MHDA- 2017/09/07 06:00
CRDT- 2017/01/20 06:00
PHST- 2016/10/19 00:00 [received]
PHST- 2017/01/11 00:00 [accepted]
PHST- 2017/01/05 00:00 [revised]
PHST- 2017/01/20 06:00 [pubmed]
PHST- 2017/09/07 06:00 [medline]
PHST- 2017/01/20 06:00 [entrez]
AID - 10.1007/s00417-017-3589-x [pii]
AID - 10.1007/s00417-017-3589-x [doi]
PST - ppublish
SO  - Graefes Arch Clin Exp Ophthalmol. 2017 May;255(5):923-934. doi: 
      10.1007/s00417-017-3589-x. Epub 2017 Jan 19.