Ranibizumab 0.3 mg for Persistent Diabetic Macular Edema After Recent, Frequent, and Chronic Bevacizumab: The ROTATE Trial

Ophthalmic Surg Lasers Imaging Retina. 2016 Nov 1;47(11):1-18. doi: 10.3928/23258160-20161031-07.

Abstract

Background and objective: To evaluate the safety and efficacy of 0.3 mg ranibizumab (Lucentis; Genentech, South San Francisco, CA) in eyes with persistent diabetic macular edema (DME) after recent, chronic, and frequent bevacizumab (Avastin; Genentech, South San Francisco, CA).

Patients and methods: Open-label, prospective study of 0.3 mg ranibizumab for eyes with persistent DME after bevacizumab. Thirty eyes randomized to a sustained group or a pro re nata (PRN) dosing group.

Results: The mean change in ETDRS best-corrected visual acuity from baseline to 1 year was +6.7 letters in the sustained group, +6.4 letters in the PRN group, and +6.5 letters overall. There was an overall mean reduction of 116 µm from baseline central subfield thickness at 1 year, with -92 µm and -127 µm decreases in the sustained and PRN groups, respectively. Adverse events included two deaths; one patient with multiple cardiopulmonary comorbidities, myocardial infarction, stroke, osteomyelitis; and mild posterior subcapsular cataracts in two eyes.

Conclusion: Ranibizumab 0.3 mg demonstrated improved visual and anatomic outcomes in patients with persistent DME following bevacizumab. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:1030-1037.].

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / adverse effects
  • Angiogenesis Inhibitors / therapeutic use
  • Bevacizumab / therapeutic use
  • Diabetic Retinopathy / drug therapy*
  • Female
  • Humans
  • Intravitreal Injections
  • Macular Edema / drug therapy*
  • Male
  • Middle Aged
  • Prospective Studies
  • Ranibizumab / adverse effects
  • Ranibizumab / therapeutic use*
  • Tomography, Optical Coherence
  • Visual Acuity

Substances

  • Angiogenesis Inhibitors
  • Bevacizumab
  • Ranibizumab