title: Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study.
abstract: OBJECTIVE
  To evaluate ranibizumab 0.5 mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for 6 months in patients with visual impairment due to diabetic macular edema (DME).
  
  
  METHODS
  A phase IIIb, 18-month, prospective, open-label, multicenter, single-arm study in the United Kingdom.
  
  
  METHODS
  Participants (N = 109) with visual impairment due to DME.
  
  
  METHODS
  Participants received 3 initial monthly ranibizumab 0.5 mg injections (day 0 to month 2), followed by individualized best-corrected visual acuity (BCVA) and optical coherence tomography-guided re-treatment with monthly (months 3-5) and subsequent bimonthly follow-up (months 6-18). Laser was allowed after month 6.
  
  
  METHODS
  Mean change in BCVA from baseline to month 12 (primary end point), mean change in BCVA and central retinal thickness (CRT) from baseline to month 18, gain of ≥10 and ≥15 letters, treatment exposure, and incidence of adverse events over 18 months.
  
  
  RESULTS
  Of 109 participants, 100 (91.7%) and 99 (90.8%) completed the 12 and 18 months of the study, respectively. The mean age was 63.7 years, the mean duration of DME was 40 months, and 77.1% of the participants had received prior laser treatment (study eye). At baseline, mean BCVA was 62.9 letters, 20% of patients had a baseline BCVA of >73 letters, and mean baseline CRT was 418.1 μm, with 32% of patients having a baseline CRT <300 μm. The mean change in BCVA from baseline to month 6 was +6.6 letters (95% confidence interval [CI], 4.9-8.3), and after institution of bimonthly treatment the mean change in BCVA at month 12 was +4.8 letters (95% CI, 2.9-6.7; P < 0.001) and +6.5 letters (95% CI, 4.2-8.8) at month 18. The proportion of participants gaining ≥10 and ≥15 letters was 24.8% and 13.8% at month 12 and 34.9% and 19.3% at month 18, respectively. Participants received a mean of 6.8 and 8.5 injections over 12 and 18 months, respectively. No new ocular or nonocular safety findings were observed during the study.
  
  
  CONCLUSIONS
  The BCVA gain achieved in the initial 6-month treatment period was maintained with an additional 12 months of bimonthly ranibizumab PRN treatment.
authors.affiliation: St. Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom. Electronic address: ian.pearce@rlbuht.nhs.uk.
authors.forename: Ian
authors.initials: I
authors.lastname: Pearce
authors.affiliation: University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Sanjiv
authors.initials: S
authors.lastname: Banerjee
authors.affiliation: James Paget University Hospital, Great Yarmouth, United Kingdom.
authors.forename: Ben J L
authors.initials: BJ
authors.lastname: Burton
authors.affiliation: Royal Victoria Hospital, Belfast, United Kingdom.
authors.forename: Usha
authors.initials: U
authors.lastname: Chakravarthy
authors.affiliation: Hull and East Yorkshire Eye Hospital, Hull, United Kingdom.
authors.forename: Louise
authors.initials: L
authors.lastname: Downey
authors.affiliation: York Teaching Hospital, York, United Kingdom.
authors.forename: Richard P
authors.initials: RP
authors.lastname: Gale
authors.affiliation: Birmingham Heartlands Hospital, Birmingham, United Kingdom.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Gibson
authors.affiliation: University Hospitals Coventry & Warwickshire, Hospital of St Cross, Rugby, United Kingdom.
authors.forename: Sergio
authors.initials: S
authors.lastname: Pagliarini
authors.affiliation: Essex County Hospital, Colchester, United Kingdom.
authors.forename: Jignesh
authors.initials: J
authors.lastname: Patel
authors.affiliation: Kings College Hospital, London, United Kingdom.
authors.forename: Sobha
authors.initials: S
authors.lastname: Sivaprasad
authors.affiliation: Novartis Pharmaceuticals UK Ltd., Surrey, United Kingdom.
authors.forename: Chris
authors.initials: C
authors.lastname: Andrews
authors.affiliation: F. Hoffmann-La Roche Ltd., Basel, Switzerland.
authors.forename: Christopher
authors.initials: C
authors.lastname: Brittain
authors.affiliation: Novartis Pharmaceuticals UK Ltd., Surrey, United Kingdom.
authors.forename: James
authors.initials: J
authors.lastname: Warburton
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069579:Ranibizumab; D019233:Retreatment; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000187:drug effects / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab