Fluocinolone Acetonide Sustained Drug Delivery Device for Chronic Central Retinal Vein Occlusion: 12-Month Results

• Published in: American journal of ophthalmology 2008-08, Vol.146 (2), p.285-291.e1
• Main Authors: Ramchandran, Rajeev S, Fekrat, Sharon, Stinnett, Sandra S, Jaffe, Glenn J
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Cataracts; Chronic Disease; Company reports; Drug Delivery Systems; Drug Implants; FDA approval; Female; Fluocinolone Acetonide - administration & dosage; Fluocinolone Acetonide - adverse effects; Fluorescein Angiography; Follow-Up Studies; Fovea Centralis - pathology; Glucocorticoids - administration & dosage; Glucocorticoids - adverse effects; Humans; Intraocular Pressure; Macular degeneration; Macular Edema - drug therapy; Macular Edema - etiology; Male; Medical sciences; Miscellaneous; Ophthalmology; Pharmaceutical industry; Pilot Projects; Prospective Studies; Retinal Vein Occlusion - complications; Retinal Vein Occlusion - drug therapy; Retinopathies; Tomography, Optical Coherence; Treatment Outcome; Visual Acuity; Vitreous Body
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2008.03.025

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 μm before surgery, respectively, to 307 and 199 μm 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.