Fort Lauderdale, FL-A fluocinolone acetonide intravitreal implant led to an improvement in visual acuity of 3 or more lines at 36 months in a significant proportion of patients with diabetic macular edema (DME) enrolled in a multicenter clinical trial.
According to P. Andrew Pearson, MD, professor and chairman, department of ophthalmology and visual sciences, and co-director, retina and vitreous service, University of Kentucky, Lexington, 27.6% of participants in the implant arm of the randomized study exhibited this level of improvement compared with 14.5% in the standard of care group (p = 0.038).
"As far as I know, this is the first trial that has shown a significant improvement in vision over years in patients with DME," Dr. Pearson said. "Improvements in vision that were seen at 2 years appeared to be maintained at 3 years."
In a presentation at the annual meeting of the Association for Research in Vision and Ophthalmology, Dr. Pearson presented 36-month results on behalf of the Fluocinolone Acetonide Study Group. However, except for visual acuity data, much of the information available at the time of presentation was based on photographic interpretations from last visit available. In many cases, that was 24 rather than 36 months.
In this study, 197 patients were enrolled and randomly assigned at a 2:1 ratio to a 0.59-mg fluocinolone acetonide implant or standard of care, which consisted of repeat laser photocoagulation or observation. Efficacy outcome measures included visual acuity change from baseline, rate of resolution of retinal thickening at the center of the macula at 12 months, change from baseline in retinal thickness at the center of the macula at 12 months, and Diabetic Retinopathy Severity Score. Safety and efficacy analyses were performed at years 1, 2, and 3, and will be performed again at year 4.
The mean age of the study participants was 62.2 ± 10.1 years, and 58.4% were male.
At 36 months, the rate of a decrease of 3 or more lines of visual acuity was 18.9% in the implant arm and 15.9% for the standard-of-care arm (p = 0.606).
Results from the last available visit indicated that resolution of edema at the center of the macula was sustained after 1 year, as were a 2+-step improvement in retinal thickness at the center of the macula and improvement in Diabetic Retinopathy Scores.
The safety data from 36 months showed that IOP remained an issue and that patients who receive this therapy should be closely monitored, Dr. Pearson said. Data showed that 59.1% of eyes that received implants versus 5.8% of eyes that received standard of care had IOP ≥30 mm Hg at any time. In addition, 37 eyes that received implants (29.1%) required filtering surgery, and the implant was removed in six eyes (4.7%).
Cataracts were also an issue and were extracted in 95% of phakic eyes with implants versus 18.5% of those with standard of care.
The fluocinolone acetonide intravitreal implant has been approved for treatment of posterior uveitis; no FDA submission has yet been filed seeking approval for its use as a therapy for DME, Dr. Pearson said.