Prospective study of a fluocinolone acetonide implant for chronic macular edema from central retinal vein occlusion: thirty-six-month results.

Abstract

To assess long-term visual outcomes and adverse events from a fluocinolone acetonide (FA) sustained drug delivery implant in eyes with chronic macular edema from central retinal vein occlusion (CRVO). Prospective interventional case series. A total of 24 eyes of 23 subjects with vision loss associated with chronic macular edema from CRVO. Implantation of an intravitreal FA sustained drug delivery system. The primary outcome measure was mean Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity letter score at 36 months after implantation. Secondary outcome measures included number of subjects with ≥ 10-letter improvement in ETDRS letter score, central foveal thickness (CFT), total macular volume, and intraocular pressure (IOP). At 1, 2, and 3 years after implantation, mean visual acuity showed gains of 4.5 (P = 0.52), 8.2 (P = 0.07), and 3.4 (P = 0.64) letters, respectively, and 32%, 56%, and 50% of study eyes, respectively, showed at least a 10-letter gain in ETDRS score. At these same time points, mean CFT improved by 247 (44%; P = 0.002), 212 (38%; P < 0.001), and 250 μm (45%; P<0.001), respectively. During the study period, all phakic eyes ultimately underwent cataract extraction, and 5 eyes underwent glaucoma surgery. The FA drug delivery system provided sustained visual acuity and anatomic benefit in patients with macular edema from CRVO, and it has promise as a therapeutic option for selected patients with this condition. The main complications were cataract and elevated IOP. The authors have no proprietary or commercial interest in any of the materials discussed in this article.