Dean Eliott, MD (Los Angeles, CA),* Brian Levy, OD, MS (Rochester, NY),* Timothy L. Comstock, OD, MS (Rochester, NY)*


This 4-year prospective, multicenter, randomized, controlled study is being conducted to investigate the safety and  efficacy of a sustained-release fluocinolone acetonide intravitreal implant in the treatment of diabetic macular edema (DME).


This study consists of 23 U.S. sites that enrolled 197 patients with persistent/recurrent DME who had received at least one macular laser treatment at least 12 weeks prior to enrollment. Subjects were randomized 2:1 into an implant group (0.59-mg implant) or standard-of-care group (repeat macular laser or observation at investigator discretion). Mean age was 62.2 years, 58.4% were male, and 77.6% were Caucasian. Outcomes included resolution of macular edema (masked stereoscopic photographs assessed by reading center), change in retinal thickness at the center of the macula (on OCT), change in diabetic retinopathy severity score (DRSS), change in visual acuity, and adverse events.


At 3 years post-implantation, treatment with sustained-release fluocinolone acetonide demonstrated statistically significant differences compared to standard of care with respect to the following: higher rate of resolution of macular edema (58% vs 30%, P<0.001); higher rate of improvement of >2 grades in retinal thickness (45% vs 24%, P<0.003); higher rate of improvement of >1 step in DRSS (13% vs 4%, P<0.001); and higher rate of improvement of =?3 lines visual acuity (28% vs 15%, P<0.05). Differences in visual acuity loss of =?3 lines were not statistically significant (19% implant vs 16% standard of care, P? 0.61). Cataracts requiring extraction (95% of phakic eyes) and increased intraocular pressure (35%) were the most serious adverse events reported. Five percent of patients with elevated IOP underwent explantation and 28% underwent a filtering procedure.


The sustained-release fluocinolone acetonide intravitreal implant provided resolution of persistent/recurrent DME, improvement in retinal thickness and diabetic retinopathy severity score, and improvement in visual acuity more frequently than standard of care at 36 months. Almost all phakic patients required cataract extraction, and one-third of patients required a surgical procedure to lower IOP.
* Financial interest disclosed