Abstract
Purpose :
Fluocinolone acetonide (FAc) 190 µg intravitreal implant provides a sustained, controlled micro-dose release of corticosteroid (0.2 μg/day of FAc) for up to 3 years. Iluvien Clinical Evidence study in Portugal (ICE-PT) is the largest cohort today to assess the effect of FAc intravitreal implant and the only study in Portugal to assess the effects in patients primarily treated with a prior intravitreal steroid. Thus, the aim was to compare retinal thickness before and after treatment with the FAc implant in people with diabetic macular edema (DME) using data from ICE-PT, a retrospective multicenter study.
Methods :
Independent data collection and analysis was performed on a cohort of 93 eyes (68 patients) from ICE-PT. This data was collected under a protocol and had ethical approval from the 4 participating centers. DME treatments and parameters of anatomical and visual effectiveness were collected for the 12 months prior and post intravitreal injection of a single FAc implant, which was administered to patients diagnosed with persistent or recurrent DME despite prior treatment (62.4% of eyes had been treated with a prior intravitreal steroids). Parameters measured included changes in central foveal thickness (CFT, µm) and measures of effectiveness included the percentage of patients achieving ≤300µm.
Results :
In this cohort, the mean age of patients was 67.4 years and 55.9% were male. The pseudophakic/phakic ratio was 69.9%:20.4%, respectively. Twelve months prior to FAc implant there was a progressive worsening of CFT from 448µm to 511 µm (p=0.024) despite receiving treatment. Following treatment with FAc implant mean CFT decreased from 511µm (baseline) to 309µm at 12 months (p<0.001). Over the same period, 59.0% of eyes achieved ≤300µm when compared with 11.8% at baseline. Mean change in visual acuity and intraocular pressure at 12 months post-FAc implant was +4.6 letters (p<0.05) and 1.0mmHg (p <0.05).
Conclusions :
Following a switch to FAc implant, the current findings reinforce the high morphological benefits to the patient and support the hypothesis being tested that beneficial effects can be achieved in patients with persistent or recurrent DME following treatment with a prior steroid.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.