Fluocinolone acetonide sustained drug delivery device for chronic central retinal vein occlusion: 12-month results

PURPOSE: To determine treatment outcomes of a long-acting intravitreal fluocinolone acetonide sustained drug delivery implant in eyes with central retinal vein occlusion (CRVO) and chronic refractory macular edema. DESIGN: Prospective, noncomparative, interventional case series. METHODS: Fourteen eyes of 14 patients with chronically persistent macular edema associated with CRVO underwent intraocular implantation of a three-year fluocinolone acetonide sustained drug delivery system. Best-corrected Early Treatment of Diabetic Retinopathy visual acuity (VA), central foveal thickness determined by optical coherence tomography, and intraocular pressure (IOP) were recorded after the first 12 months after implant insertion. RESULTS: The median (range) vein occlusion and macular edema duration were 12.5 months (range, seven to 49). No eye experienced intraoperative complications. At baseline, median VA was 20/126, improved to 20/60 by two months, and was 20/80 by 12 months. A significant proportion of eyes had gained lines of VA at 12 months compared with baseline (P = .002). At 12 months, the mean and median central retinal thickness decreased from 622 and 600 microm before surgery, respectively, to 307 and 199 microm after surgery, respectively (P = .008). By month 12, cataract had developed in all five phakic patients, and 13 of 14 eyes required medical or surgical IOP-lowering interventions. CONCLUSIONS: VA improved and macular edema decreased in a significant proportion of implanted eyes with chronic, CRVO-associated macular edema. Cataract formation and elevated IOP, the main side effects, were managed, respectively, with cataract extraction and medical or surgical IOP control, or both. This system is a promising novel alternative to currently available treatments for this challenging patient population.