title: Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study.
abstract: OBJECTIVE
  To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME).
  
  
  METHODS
  Prospective, randomized, interventional, multicenter clinical trial.
  
  
  METHODS
  One hundred twenty-six patients with DME.
  
  
  METHODS
  Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ.
  
  
  METHODS
  The mean change from baseline in best-corrected visual acuity (BCVA) at month 24.
  
  
  RESULTS
  After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively.
  
  
  CONCLUSIONS
  Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Quan Dong
authors.initials: QD
authors.lastname: Nguyen
authors.forename: Syed Mahmood
authors.initials: SM
authors.lastname: Shah
authors.forename: Afsheen A
authors.initials: AA
authors.lastname: Khwaja
authors.forename: Roomasa
authors.initials: R
authors.lastname: Channa
authors.forename: Elham
authors.initials: E
authors.lastname: Hatef
authors.forename: Diana V
authors.initials: DV
authors.lastname: Do
authors.forename: David
authors.initials: D
authors.lastname: Boyer
authors.forename: Jeffery S
authors.initials: JS
authors.lastname: Heier
authors.forename: Prema
authors.initials: P
authors.lastname: Abraham
authors.forename: Allen B
authors.initials: AB
authors.lastname: Thach
authors.forename: Eugene S
authors.initials: ES
authors.lastname: Lit
authors.forename: Bradley S
authors.initials: BS
authors.lastname: Foster
authors.forename: Erik
authors.initials: E
authors.lastname: Kruger
authors.forename: Pravin
authors.initials: P
authors.lastname: Dugel
authors.forename: Thomas
authors.initials: T
authors.lastname: Chang
authors.forename: Arup
authors.initials: A
authors.lastname: Das
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Ciulla
authors.forename: John S
authors.initials: JS
authors.lastname: Pollack
authors.forename: Jennifer I
authors.initials: JI
authors.lastname: Lim
authors.forename: Dean
authors.initials: D
authors.lastname: Eliott
authors.forename: Dean
authors.initials: D
authors.lastname: Eliot
authors.forename: Peter A
authors.initials: PA
authors.lastname: Campochiaro
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D003131:Combined Modality Therapy; D003930:Diabetic Retinopathy / Q000188:drug therapy*; D005451:Fluorescein Angiography; D006801:Humans; D007267:Injections; D017075:Laser Coagulation; D008269:Macular Edema / Q000188:drug therapy*; D011446:Prospective Studies; D000069579:Ranibizumab; D019233:Retreatment; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab