title: Ranibizumab or Bevacizumab for Neovascular Age-Related Macular Degeneration According to the Lucentis Compared to Avastin Study Treat-and-Extend Protocol: Two-Year Results.
abstract: OBJECTIVE
  To compare the efficacy and safety of bevacizumab (Avastin; F. Hoffmann-La Roche Ltd, Basel, Switzerland) versus ranibizumab (Lucentis; Novartis Pharma AG, Basel, Switzerland) for neovascular age-related macular degeneration (nAMD) after 2 years when using a treat-and-extend protocol.
  
  
  METHODS
  Multicenter, randomized, noninferiority trial with a noninferiority limit of 5 letters.
  
  
  METHODS
  Patients 50 years of age or older with previously untreated nAMD in 1 eye and best-corrected visual acuity 20/25 to 20/320.
  
  
  METHODS
  Patients were assigned randomly to receive intravitreal injections with either ranibizumab 0.5 mg or bevacizumab 1.25 mg. Injections were given every 4 weeks until inactive disease was achieved. The treatment interval then was extended by 2 weeks at a time up to a maximum of 12 weeks. In the event of a recurrence, the treatment interval was shortened by 2 weeks at a time.
  
  
  METHODS
  Mean change in visual acuity at 2 years.
  
  
  RESULTS
  Of a total of 441 randomized patients, 339 patients (79%) completed the 2-year visit. According to per-protocol analysis at 2 years, bevacizumab was equivalent to ranibizumab, with 7.4 and 6.6 letters gained, respectively (95% confidence interval [CI] of mean difference, -4.1 to 2.5; P = 0.634). Intention-to-treat analysis was concordant, with a gain of 7.8 letters for bevacizumab and 7.5 letters for ranibizumab (95% CI of mean difference, -3.2 to 2.7; P = 0.873). The 2-year results did not show any significant difference in mean central retinal thickness, with a decrease of -113 μm for bevacizumab and -122 μm for ranibizumab (95% CI of mean difference, -32 to 15; P = 0.476). There was a statistically significant difference between the drugs regarding the number of treatments given, with 18.2 injections for bevacizumab and 16.0 injections for ranibizumab (95% CI of mean difference, -3.4 to -1.0; P ≤ 0.001). The number of serious adverse events was similar between the groups over the course of the study.
  
  
  CONCLUSIONS
  At 2 years, bevacizumab and ranibizumab had an equivalent effect on visual acuity and reduction of central retinal thickness when administered according to a treat-and-extend protocol for nAMD. There was no significant difference in the number of serious adverse events between the treatment groups.
authors.affiliation: Department of Ophthalmology, Oslo University Hospital, Oslo, Norway. Electronic address: karinabb@medisin.uio.no.
authors.forename: Karina
authors.initials: K
authors.lastname: Berg
authors.affiliation: Department of Ophthalmology, Betanien Hospital, Skien, Norway.
authors.forename: Emina
authors.initials: E
authors.lastname: Hadzalic
authors.affiliation: Department of Ophthalmology, Vestre Viken Hospital Trust, Drammen, Norway.
authors.forename: Inger
authors.initials: I
authors.lastname: Gjertsen
authors.affiliation: Department of Ophthalmology, Stavanger University Hospital, Stavanger, Norway.
authors.forename: Vegard
authors.initials: V
authors.lastname: Forsaa
authors.affiliation: Department of Ophthalmology, Østfold Hospital, Moss, Norway.
authors.forename: Lars Haakon
authors.initials: LH
authors.lastname: Berger
authors.affiliation: The Retina Clinic, Aleris, Oslo, Norway.
authors.forename: Bettina
authors.initials: B
authors.lastname: Kinge
authors.affiliation: Department of Ophthalmology, Vestfold Hospital, Tønsberg, Norway.
authors.forename: Hans
authors.initials: H
authors.lastname: Henschien
authors.affiliation: Department of Ophthalmology, University Hospital of Northern Norway, Tromsø, Norway.
authors.forename: Kristian
authors.initials: K
authors.lastname: Fossen
authors.affiliation: Department of Ophthalmology, Innlandet Hospital, Elverum, Norway.
authors.forename: Slavica
authors.initials: S
authors.lastname: Markovic
authors.affiliation: Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.
authors.forename: Terje R
authors.initials: TR
authors.lastname: Pedersen
authors.affiliation: Department of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.
authors.forename: Leiv
authors.initials: L
authors.lastname: Sandvik
authors.affiliation: Department of Ophthalmology, Oslo University Hospital, Oslo, Norway.
authors.forename: Ragnheiður
authors.initials: R
authors.lastname: Bragadóttir
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D000068258:Bevacizumab / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D006801:Humans; D058449:Intravitreal Injections; D008268:Macular Degeneration / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage*; D015861:Retinal Neovascularization / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D012189:Retrospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D000068258:Bevacizumab; D000069579:Ranibizumab