Monthly versus as-needed ranibizumab injections in patients with retinal vein occlusion: the SHORE study

Ophthalmology. 2014 Dec;121(12):2432-42. doi: 10.1016/j.ophtha.2014.06.011. Epub 2014 Jul 21.


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.

Design: Randomized, open-label, vision-examiner masked, 15-month study.

Participants: 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.

Main outcome measures: 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Angiogenesis Inhibitors / administration & dosage*
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Drug Administration Schedule
  • Female
  • Humans
  • Intravitreal Injections
  • Macular Edema / drug therapy*
  • Macular Edema / etiology
  • Macular Edema / physiopathology
  • Male
  • Middle Aged
  • Ranibizumab
  • Retinal Vein Occlusion / complications
  • Retinal Vein Occlusion / drug therapy*
  • Retinal Vein Occlusion / physiopathology
  • Visual Acuity / physiology


  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • Ranibizumab