Ranibizumab for High-Risk Proliferative Diabetic Retinopathy: An Exploratory Randomized Controlled Trial

Ophthalmologica. 2016;235(1):34-41. doi: 10.1159/000442026. Epub 2015 Dec 3.

Abstract

Purpose: To compare the efficacy and safety of intravitreal ranibizumab (IVR) in monotherapy or associated with panretinal photocoagulation (PRP) versus conventional PRP, for high-risk proliferative diabetic retinopathy (PDR) without vitreoretinal traction.

Procedures: Multicenter randomized trial, with 3 treatment arms: PRP versus IVR alone and PRP + IVR combined treatment. Follow-up was performed at months 3, 6 and 12.

Results: Thirty-five subjects were randomized and 32 used for analysis. Complete regression of neovessels elsewhere occurred in 100% (PRP + IVR), 75% (IVR) and 69.2% (PRP) and for neovessels of the disk in 44.4% (PRP + IVR), 37.5% (IVR) and 30.8% (PRP). During the 1-year duration of treatment, there was no need for laser rescue treatment in IVR-treated eyes.

Conclusions: This trial suggests that the use of IVR is safe and may have a beneficial effect in the treatment of eyes with high-risk PDR.

Message: Ranibizumab appears to have a place in the treatment of PDR.

Trial registration: ClinicalTrials.gov NCT01280929.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Angiogenesis Inhibitors / therapeutic use*
  • Combined Modality Therapy
  • Diabetic Retinopathy / drug therapy
  • Diabetic Retinopathy / physiopathology
  • Diabetic Retinopathy / surgery
  • Diabetic Retinopathy / therapy*
  • Female
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections
  • Laser Coagulation*
  • Lasers, Solid-State / therapeutic use*
  • Male
  • Middle Aged
  • Ranibizumab / therapeutic use*
  • Retreatment
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity / physiology

Substances

  • Angiogenesis Inhibitors
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT01280929