Effectiveness and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema: A Real-World Experience

Ophthalmologica. 2019;241(1):9-16. doi: 10.1159/000492132. Epub 2018 Nov 8.

Abstract

Introduction: There are few real-life studies on the intravitreal 0.7-mg dexamethasone implant for the treatment of diabetic macular edema (DME) conducted in Latin America. We aimed to assess the effectiveness and safety of this implant in clinical practice.

Methods: Twenty-seven centers from Brazil and one from Argentina provided information on patients with DME treated with Ozurdex. The efficacy outcome variables were best-corrected visual acuity (BCVA) in Snellen and central retinal thickness (CRT). Safety was assessed by the elevation in intraocular pressure (IOP), occurrence of cataracts, and adverse events.

Results: A total of 329 eyes (both treated cases and naïve eyes) from 282 patients underwent treatment. The time since diagnosis of DME ranged from 1 to 156 months. The median BCVA was 0.7 logMAR/50 letters at baseline and 0.3 logMAR/70 letters after treatment (both p < 0.001). Median CRT values decreased from 425 µm at baseline to 270 µm after treatment (p < 0.001). Increases in IOP of at least 10 mm Hg were observed in 7.4% of eyes, and 4% of eyes had cataract evolution. No cases of endophthalmitis were reported.

Conclusion: These real-life results suggest that the intravitreal dexamethasone implant is effective and safe for eyes with DME.

Keywords: Anti-vascular endothelial growth factor; Diabetic macular edema; Drug delivery; Vascular endothelial growth factor.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Dexamethasone / administration & dosage*
  • Diabetic Retinopathy / complications*
  • Diabetic Retinopathy / diagnosis
  • Diabetic Retinopathy / drug therapy
  • Drug Implants
  • Female
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage
  • Humans
  • Intravitreal Injections
  • Macular Edema / diagnosis
  • Macular Edema / drug therapy*
  • Macular Edema / etiology
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome
  • Visual Acuity*

Substances

  • Drug Implants
  • Glucocorticoids
  • Dexamethasone