Visual Acuity Outcomes in Diabetic Macular Edema With Fluocinolone Acetonide 0.2 μg/Day Versus Ranibizumab Plus Deferred Laser (DRCR Protocol I)

Ophthalmic Surg Lasers Imaging Retina. 2018 Sep 1;49(9):698-706. doi: 10.3928/23258160-20180831-08.

Abstract

Background and objective: Visual outcomes of the FAME study (0.2 μg/day fluocinolone acetonide [FAc]) and Protocol I (0.5 mg ranibizumab plus deferred laser) were compared using the area under the curve (AUC) analysis method.

Patients and methods: Best-corrected visual acuity (BCVA) data collected during a period of 3 years of follow-up for patients enrolled in FAME or Protocol I were used to calculate AUC of the change in BCVA over a time curve.

Results: In the overall population, there was a greater treatment effect for ranibizumab plus deferred laser compared with FAc. However, for subgroups of pseudophakic eyes, eyes with chronic diabetic macular edema (DME), and pseudophakic eyes with chronic DME, ranibizumab plus deferred laser and FAc were not found to be significantly different. The ranibizumab group received a median of 14 injections during a 36-month period compared with a mean of 1.3 injections in the FAc group.

Conclusion: In pseudophakic and chronic DME subgroups, FAc was comparable to ranibizumab plus deferred laser with fewer injections. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:698-706.].

Publication types

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

MeSH terms

  • Angiogenesis Inhibitors / administration & dosage
  • Diabetic Retinopathy / complications
  • Diabetic Retinopathy / diagnosis
  • Diabetic Retinopathy / therapy*
  • Female
  • Fluocinolone Acetonide / administration & dosage*
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage
  • Humans
  • Intravitreal Injections
  • Laser Coagulation / methods*
  • Macular Edema / diagnosis
  • Macular Edema / etiology
  • Macular Edema / therapy*
  • Male
  • Middle Aged
  • Ranibizumab / administration & dosage*
  • Treatment Outcome
  • Visual Acuity*

Substances

  • Angiogenesis Inhibitors
  • Glucocorticoids
  • Fluocinolone Acetonide
  • Ranibizumab