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

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 mu g/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 mu g/day FAc implant administration.