title: Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study.
abstract: OBJECTIVE
  To demonstrate non-inferiority of ranibizumab treat-and-extend (T&E) with/without laser to ranibizumab pro re nata (PRN) for best-corrected visual acuity (BCVA) in patients with diabetic macular oedema (DMO).
  
  
  METHODS
  A 24-month single-masked study with patients randomised 1:1:1 to T&E+laser (n=121), T&E (n=128) or PRN (control; n=123). All patients received monthly injections until BCVA stabilisation. The investigator decided on re-treatment in the PRN and treatment-interval adaptations in the T&E groups based on loss of BCVA stability due to DMO activity. Likewise, laser treatment was at investigator's discretion. Collectively, these features reflect a real-life scenario. Endpoints included mean average change in BCVA from baseline to months 1-12 (primary), mean BCVA change from baseline to months 12 and 24, treatment exposure and safety profile.
  
  
  RESULTS
  Both T&E regimens were non-inferior to PRN based on mean average BCVA change from baseline to months 1-12 (T&E+laser: +5.9 and T&E: +6.1 vs PRN: +6.2 letters; both p<0.0001). Mean BCVA change at month 24 was similar across groups (+8.3, +6.5 and +8.1 letters, respectively). The mean number of injections was 12.4 and 12.8 in the T&E+laser and T&E groups and 10.7 in the PRN group. The T&E regimens showed 46% reduction in the number of clinic visits. Over 70% of patients maintained their BCVA, with treatment intervals of ≥2 months over 24 months. Safety profile was consistent with that described in the product information.
  
  
  CONCLUSIONS
  T&E is a feasible treatment option for patients with DMO, with a potential to reduce treatment burden. Slightly more injections were required versus PRN, likely due to the specifics of the T&E regimen applied here.
  
  
  BACKGROUND
  NCT01171976.
authors.affiliation: Department of Ophthalmology, Vista Klinik, Binningen, Switzerland Kantonsspital Baselland, Eye Clinic, Liestal, Switzerland University of Basel, Basel, Switzerland.
authors.forename: Christian
authors.initials: C
authors.lastname: Prünte
authors.affiliation: Centre d'Imagerie et Laser, Paris, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Fajnkuchen
authors.affiliation: Royal Eye Hospital, Manchester, UK.
authors.forename: Sajjad
authors.initials: S
authors.lastname: Mahmood
authors.affiliation: PTV Foundation, University of Rome "Tor Vergata", Rome, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Ricci
authors.affiliation: Department of Ophthalmology, Vista Klinik, Binningen, Switzerland University of Basel, Basel, Switzerland.
authors.forename: Katja
authors.initials: K
authors.lastname: Hatz
authors.affiliation: Department of Ophthalmology, University Hospital, Hradec Králové, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Studnička
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Bezlyak
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Soumil
authors.initials: S
authors.lastname: Parikh
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: William John
authors.initials: WJ
authors.lastname: Stubbings
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Wenzel
authors.affiliation: AIBILI, Coimbra, Portugal Coimbra Hospital and University Centre, Coimbra, Portugal Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
authors.forename: João
authors.initials: J
authors.lastname: Figueira
mesh_terms: D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D003930:Diabetic Retinopathy / Q000150:complications* / Q000175:diagnosis; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008266:Macula Lutea / Q000000981:diagnostic imaging*; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage*; D012189:Retrospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors*; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab
keywords: Clinical Trial; Macula; Treatment Lasers; Treatment Medical; Vision