Abstract
Purpose :
ILUVIEN is indicated for the treatment of chronic diabetic macular edema (DME) delivering a sustained microdose of the corticosteroid fluocinolone acetonide (FAc) for up to 3 years into the vitreous of the eye. The pharmacokinetics of FAc in the vitrectomized eyes is not clearly defined. Hence, the purpose of the current study was to determine pharmacodynamics of ILUVIEN in vitrectomized eyes.
Methods :
A retrospective monocentric audit was conducted in 33 eyes of 25 patients with DME. In 32 out of the 33 eyes, a core or a subtotal pars plana vitrectomy (PPV) had been performed before all eyes were subsequently treated with a single ILUVIEN implant (October 2013 - September 2016). ILUVIEN was administered after a suboptimal response to a prior DME therapy. Efficacy (visual acuity [VA] ) and safety parameters (intraocular pressure [IOP] ) were assessed at baseline and after ILUVIEN treatment (average follow-up was 203.2 days or 6.7 months). Values are reported as means throughout.
Results :
33 eyes with a mean age of 61.4 years were recruited. 13 eyes were phakic, 22 eyes pseudophakic. Prior DME therapies included: ranibizumab (n=19 eyes), dexamethasone implants (n=12), panretinal photocoagulation (n=19) and focal laser (n=7). ILUVIEN therapy led to a mean gain in VA of +5.1 ETDRS letters from baseline. In patients previously treated with dexamethasone, the gain in VA was +3.8 letters prior to administration of ILUVIEN. Overall, VA increased or was maintained (≥ 0 letter gain) in 72.7% of eyes.
After implantation of ILUVIEN, no other therapies for treatment of DME were applied. In six (of 13) eyes (46%) cataract extraction was required during the f/u-period. IOP elevation over 30 mm Hg occurred in one (3%) eye (successfully lowered after trabeculectomy), in seven eyes (21.2%) a moderately increased IOP was effectively managed topically.
Conclusions :
In these previously treated vitrectomized eyes there was a mean improvement in VA of more than 5 letters with a single ILUVIEN implant, which was greater than the mean VA gain to prior treatment with dexamethasone. With the exception of one eye, IOP increase did not seem to have a significant impact onto the post-ILUVIEN therapy.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.