title: Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study.
abstract: OBJECTIVE
  Assess the 12-month efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema after central retinal vein occlusion (CRVO).
  
  
  METHODS
  Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
  
  
  METHODS
  We included 392 patients with macular edema after CRVO.
  
  
  METHODS
  Eligible patients were randomized 1:1:1 to receive 6 monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections. After 6 months, all patients with BCVA ≤20/40 or central subfield thickness ≥250 μm could receive ranibizumab.
  
  
  METHODS
  Mean change from baseline best-corrected visual acuity (BCVA) letter score at month 12, additional parameters of visual function, central foveal thickness (CFT), and other anatomic changes were assessed.
  
  
  RESULTS
  Mean (95% confidence interval) change from baseline BCVA letter score at month 12 was 13.9 (11.2-16.5) and 13.9 (11.5-16.4) in the 0.3 mg and 0.5 mg groups, respectively, and 7.3 (4.5-10.0) in the sham/0.5 mg group (P<0.001 for each ranibizumab group vs. sham/0.5 mg). The percentage of patients who gained ≥15 letters from baseline BCVA at month 12 was 47.0% and 50.8% in the 0.3 mg and 0.5 mg groups, respectively, and 33.1% in the sham/0.5 mg group. On average, there was a marked reduction in CFT after the first as-needed injection of 0.5 mg ranibizumab in the sham/0.5 mg group to the level of the ranibizumab groups, which was sustained through month 12. No new ocular or nonocular safety events were identified.
  
  
  CONCLUSIONS
  On average, treatment with ranibizumab as needed during months 6 through 11 maintained the visual and anatomic benefits achieved by 6 monthly ranibizumab injections in patients with macular edema after CRVO, with low rates of ocular and nonocular safety events. After sham injections for 6 months, treatment with ranibizumab as needed for 6 months resulted in rapid reduction in CFT in the sham/0.5 mg group to a level similar to that in the 2 ranibizumab treatment groups and an improvement in BCVA, but not to the same level as that in the 2 ranibizumab groups. Intraocular injections of ranibizumab provide an effective treatment for macular edema after CRVO.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors.affiliation: Departments of Ophthalmology and Neuroscience, The Johns Hopkins School of Medicine, Baltimore, MD 21287-9277, USA. pcampo@jhmi.edu
authors.forename: Peter A
authors.initials: PA
authors.lastname: Campochiaro
authors.forename: David M
authors.initials: DM
authors.lastname: Brown
authors.forename: Carl C
authors.initials: CC
authors.lastname: Awh
authors.forename: S Young
authors.initials: SY
authors.lastname: Lee
authors.forename: Sarah
authors.initials: S
authors.lastname: Gray
authors.forename: Namrata
authors.initials: N
authors.lastname: Saroj
authors.forename: Wendy Yee
authors.initials: WY
authors.lastname: Murahashi
authors.forename: Roman G
authors.initials: RG
authors.lastname: Rubio
mesh_terms: D000293:Adolescent; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005451:Fluorescein Angiography; D006801:Humans; D056965:Injections, Intraocular; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D000069579:Ranibizumab; D012170:Retinal Vein Occlusion / Q000150:complications* / Q000175:diagnosis; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab