title: Five-Year Outcomes of Ranibizumab With Prompt or Deferred Laser Versus Laser or Triamcinolone Plus Deferred Ranibizumab for Diabetic Macular Edema.
abstract: OBJECTIVE
  To compare long-term vision and anatomic effects of ranibizumab with prompt or deferred laser vs laser or triamcinolone + laser with very deferred ranibizumab in diabetic macular edema (DME).
  
  
  METHODS
  Randomized clinical trial.
  
  
  METHODS
  Eight hundred and twenty-eight study eyes (558 [67%] completed the 5-year visit), at 52 sites, with visual acuity 20/32 to 20/320 and DME involving the central macula were randomly assigned to intravitreous ranibizumab (0.5 mg) with either (1) prompt or (2) deferred laser; (3) sham injection + prompt laser; or (4) intravitreous triamcinolone (4 mg) + prompt laser. The latter 2 groups could initiate ranibizumab as early as 74 weeks from baseline, for persistent DME with vision impairment. The main outcome measures were visual acuity, optical coherence central subfield thickness, and number of injections through 5 years.
  
  
  RESULTS
  At 5 years mean (± standard deviation) change in Early Treatment Diabetic Retinopathy Study visual acuity letter scores from baseline in the ranibizumab + deferred laser (N = 111), ranibizumab + prompt laser (N = 124), laser/very deferred ranibizumab (N = 198), and triamcinolone + laser/very deferred ranibizumab (N = 125) groups were 10 ± 13, 8 ± 13, 5 ± 14, and 7 ± 14, respectively. The difference (95% confidence interval) in mean change between ranibizumab + deferred laser and laser/very deferred ranibizumab and triamcinolone + laser/very deferred ranibizumab was 4.4 (1.2-7.6, P = .001) and 2.8 (-0.9 to 6.5, P = .067), respectively, at 5 years.
  
  
  CONCLUSIONS
  Recognizing limitations of follow-up available at 5 years, eyes receiving initial ranibizumab therapy for center-involving DME likely have better long-term vision improvements than eyes managed with laser or triamcinolone + laser followed by very deferred ranibizumab for persistent thickening and vision impairment.
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Susan B
authors.initials: SB
authors.lastname: Bressler
authors.affiliation: Jaeb Center for Health Research, Inc, Tampa, Florida. Electronic address: drcrstat2@jaeb.org.
authors.forename: Adam R
authors.initials: AR
authors.lastname: Glassman
authors.affiliation: Jaeb Center for Health Research, Inc, Tampa, Florida.
authors.forename: Talat
authors.initials: T
authors.lastname: Almukhtar
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Neil M
authors.initials: NM
authors.lastname: Bressler
authors.affiliation: National Eye Institute, Bethesda, Maryland.
authors.forename: Frederick L
authors.initials: FL
authors.lastname: Ferris
authors.affiliation: Southeastern Retina Associates, PC, Knoxville, Tennessee.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Googe
authors.affiliation: Department of Ophthalmology, University of Florida College of Medicine, Jacksonville, Florida.
authors.forename: Shailesh K
authors.initials: SK
authors.lastname: Gupta
authors.affiliation: Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Lee M
authors.initials: LM
authors.lastname: Jampol
authors.affiliation: Jaeb Center for Health Research, Inc, Tampa, Florida.
authors.forename: Michele
authors.initials: M
authors.lastname: Melia
authors.affiliation: Palmetto Retina Center, Columbia, South Carolina.
authors.forename: John A
authors.initials: JA
authors.lastname: Wells
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000627:therapeutic use*; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000187:drug effects / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D005938:Glucocorticoids; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D014222:Triamcinolone Acetonide; D000069579:Ranibizumab