Short-term vision gains at 12 weeks correlate with long-term vision gains at 2 years: results from the BEVORDEX randomised clinical trial of bevacizumab versus dexamethasone implants for diabetic macular oedema

Br J Ophthalmol. 2018 Apr;102(4):479-482. doi: 10.1136/bjophthalmol-2017-310737. Epub 2017 Aug 4.

Abstract

Aim: To determine whether early vision gains predict long-term visual outcomes in the BEVORDEX randomised clinical trial of bevacizumab or dexamethasone implants for diabetic macular oedema.

Methods: Post hoc analysis of 68 study eyes (77%) that completed 2 years follow-up of the BEVORDEX multicentre randomised clinical trial set in Australia (ClinicalTrials.gov identifier: NCT01298076). Study eyes from both groups were combined and stratified by visual acuity (VA) change in the first 12 weeks in to three groups: (a) suboptimal gain: <5 letters gain (includes VA loss), (b) moderate gain: 5-9 letters gain, (c) pronounced gain: ≥10 letters gain. This was correlated with VA outcome at 104 weeks taking into account treatment allocation and baseline lens status.

Results: The change in VA in the first 12 weeks was significantly correlated with VA change at 104 weeks (p<0.001). This was independent of treatment allocation (p=0.353) and lens status at baseline (p=0.593). The change in central macular thickness at 12 weeks did not correlate with VA gain at 104 weeks (p=0.847).

Conclusion: Short-term visual gain at 12 weeks was strongly correlated with long-term vision improvement independent of treatment allocation or baseline lens status. Early improvement in central macular thickness was not predictive of long-term visual outcomes.

Trial registration number: NCT01298076, Post-results.

Keywords: bevacizumab; dexamethasone; diabetic macular oedema; steroid.

Publication types

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

MeSH terms

  • Angiogenesis Inhibitors / therapeutic use*
  • Anti-Inflammatory Agents / therapeutic use*
  • Bevacizumab / therapeutic use*
  • Dexamethasone / therapeutic use*
  • Diabetic Retinopathy / drug therapy*
  • Diabetic Retinopathy / physiopathology
  • Drug Implants
  • Humans
  • Macular Edema / drug therapy*
  • Macular Edema / physiopathology
  • Regression Analysis
  • Visual Acuity / physiology

Substances

  • Angiogenesis Inhibitors
  • Anti-Inflammatory Agents
  • Drug Implants
  • Bevacizumab
  • Dexamethasone

Associated data

  • ClinicalTrials.gov/NCT01298076