title: Monthly versus as-needed ranibizumab injections in patients with retinal vein occlusion: the SHORE study.
abstract: OBJECTIVE
  To compare pro re nata (PRN) and monthly injections of 0.5 mg ranibizumab in retinal vein occlusion (RVO) patients stabilized by monthly injections.
  
  
  METHODS
  Randomized, open-label, vision-examiner masked, 15-month study.
  
  
  METHODS
  Subjects with macular edema secondary to branch or central RVO.
  
  
  METHODS
  Subjects received monthly injections of 0.5 mg ranibizumab for 7 months and those meeting stability criteria between months 7 and 14 were randomized (1:1) to PRN injections versus continued monthly injections. Non-randomized (NR) subjects (never met stability criteria) received monthly injections.
  
  
  METHODS
  The primary endpoint was the slope of change in best-corrected visual acuity (BCVA) between months 7 and 15.
  
  
  RESULTS
  There was no significant difference in the slope of change in BCVA between months 7 and 15 in patients treated PRN versus those treated with monthly injections (P = 0.509). Mean (± standard deviation) change from baseline BCVA in Early Treatment Diabetic Retinopathy Study letter score at month 15 was 21.0 ± 14.1 in the PRN group (n = 82) versus 18.7 ± 14.1 in the monthly group (n = 80) and 14.5 ± 14.7 in NR subjects (n = 13). The percentage of subjects who achieved BCVA ≥ 20/40 at month 15 was 76.8% in the PRN group, 71.3% in the monthly group, and 46.2% in NR subjects. The mean (± standard deviation) change from baseline central subfield thickness was -247.8 ± 207.5 μm in the PRN group, -289.9 ± 177.2 μm in the monthly group, and -93.2 ± 225.2 μm in NR subjects. There were no significant differences in mean BCVA gains or central subfield thickness reductions at month 15 between the PRN and monthly injection groups (all > 0.05).
  
  
  CONCLUSIONS
  After edema resolution from 7 or more monthly ranibizumab injections in RVO subjects, visual outcomes at month 15 were excellent and not significantly different in subjects treated PRN versus those who continued monthly injections.
authors: The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: pcampo@jhmi.edu.
authors: Peter A
authors: PA
authors: Campochiaro
authors: Retina Consultants Houston, Houston, Texas.
authors: Charles C
authors: CC
authors: Wykoff
authors: Medical Center Ophthalmology Associates, San Antonio, Texas.
authors: Michael
authors: M
authors: Singer
authors: Department of Ophthalmology, California Pacific Medical Center, San Francisco, California.
authors: Robert
authors: R
authors: Johnson
authors: Southeast Retina Center, Augusta, Georgia.
authors: Dennis
authors: D
authors: Marcus
authors: Genentech, Inc., South San Francisco, California.
authors: Linda
authors: L
authors: Yau
authors: Genentech, Inc., South San Francisco, California.
authors: Gary
authors: G
authors: Sternberg
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab; D012170:Retinal Vein Occlusion / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab