Characterization of Intraocular Pressure Increases and Management Strategies Following Treatment With Fluocinolone Acetonide Intravitreal Implants in the FAME Trials

Ophthalmic Surg Lasers Imaging Retina. 2016 May 1;47(5):426-35. doi: 10.3928/23258160-20160419-05.

Abstract

Background and objective: To compare elevated intraocular pressure (IOP) management and outcomes among patients with diabetic macular edema who received fluocinolone acetonide (FAc) implants versus sham-control treatment and explore the prior ocular steroid exposure impact on IOP outcomes.

Patients and methods: Best-corrected visual acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study charts or electronic VA testers. Goldmann applanation tonometry was used to measure IOP.

Results: Elevated IOP was more common in FAc-versus sham control-treated patients. Medication, and less often trabeculoplasty or surgery, was used to lower IOP without affecting VA outcomes. No patient treated with 0.2 µg/day FAc who received prior ocular steroid required IOP-lowering surgery.

Conclusion: Elevated IOP may occur following FAc implant receipt; however, in the present study, it was manageable and did not impact vision outcomes. Patients previously treated with ocular steroid did not require IOP-lowering surgery following 0.2 µg/day FAc implant administration. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:426-435.].

Publication types

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

MeSH terms

  • Antihypertensive Agents / therapeutic use
  • Diabetic Retinopathy / complications
  • Diabetic Retinopathy / drug therapy*
  • Diabetic Retinopathy / physiopathology
  • Disease Management*
  • Dose-Response Relationship, Drug
  • Drug Implants*
  • Female
  • Fluocinolone Acetonide / administration & dosage
  • Fluocinolone Acetonide / adverse effects*
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / adverse effects
  • Humans
  • Intraocular Pressure / drug effects
  • Intraocular Pressure / physiology*
  • Macular Edema / drug therapy*
  • Macular Edema / etiology
  • Macular Edema / physiopathology
  • Male
  • Middle Aged
  • Ocular Hypertension / chemically induced*
  • Ocular Hypertension / physiopathology
  • Ocular Hypertension / therapy
  • Practice Guidelines as Topic
  • Time Factors
  • Tonometry, Ocular
  • Trabeculectomy / methods
  • Treatment Outcome
  • Visual Acuity
  • Vitreous Body

Substances

  • Antihypertensive Agents
  • Drug Implants
  • Glucocorticoids
  • Fluocinolone Acetonide