SVMPharma’s real-world evidence helped deliver a unique real-world multicentre study in Portugal (ICEPT) looking at the clinical outcomes of fluocinolone acetonide implant (ILUVIEN®) in clinical practice for diabetic macular oedema (DMO) patients. Our real-world evidence provided valuable insights and helped show a marked reduction in odema in 66% of DMO patients’ eyes (n=75) in real-world clinical practice.
A retrospective cohort study of the clinical outcomes of ILUVIEN in four ophthalmology centres in Portugal: The results of the ILUVIEN clinical evidence study in Portugal (ICEPT)
A. Carniero, A Meireles, J. Castro Sousa, C. Teixeria
Purpose: The Portuguese ILUVIEN Clinical Evidence study (ICEPT) aims to evaluate the effectiveness of the fluocinolone acetonide (FAc) implant in patients with persistent and recurrent diabetic macular edema (DME). The study is unique as it allows DME progression to be monitored 12 months prior to and following ILUVIEN therapy. Given that patients treated with ILUVIEN would have experienced an inadequate response to prior therapies, we tested the hypothesis that switching from the current standard of care to ILUVIEN would lead to beneficial effects (stabilization or even an improvement) in terms of vision and retinal structure.
Setting: This is a retrospective, multicentre (n=4), observational study currently ongoing in Portugal and involving patients with DME that were treated with the current standard of care before being switched to ILUVIEN.
Methods: Patient selection: Data was collected from 102 patients with DME. From this patients were then included if they had records for the 12 months prior to ILUVIEN and at least two followup time points during the 12 months following ILUVIEN administration (i.e. n=77 patients / 113 patient eyes). A single ILUVIEN implant was administered at baseline (day zero). Parameters measured: These included visual acuity (VA; reported as Early Treatment Diabetic Retinopathy Study [ETDRS] letters), central foveal thickness (CFT; µm) and intraocular pressure (IOP; mmHg). DME therapies were also recorded to enable the comparison of the intravitreal drugs utilized in the 12 months pre and postILUVIEN. Patient demographics: The mean age of patients was 68.4±8.8 years (mean±SD; range, 47 to 90) and there was a relatively even split between male and female patients (55% and 45%, respectively). 34 of 77 patients (44.2%) were phakic at baseline and on average DME patients waited 5.6±3.3 years (range, 1.12 to 15.60) before the injection of an ILUVIEN implant.
Results: Between days 365 and 0, VA and CFT worsened with mean VA declining by 3.4 letters from 59.5±17.9 letters and CFT increasing by 58.5 µm from 442.0 µm. At day +365 there was a mean increase in VA of 8.7 letters from 56.5 letters (day zero) and a decrease in CFT from 500.8 µm to 291.6 µm. At day +365 there was also a marked reduction in edema with 66% of eyes (n=75) having a CFT <350 µm (vs. 23% [n=26] at day zero). Shortacting steroids were predominantly used to treat DME (66% of eyes [n=75]) prior to ILUVIEN and decreased dramatically by day +365 (2% [n=7]), although the mean number of treatments given to patients remained the same (1.3 vs. 1.1; day 365 vs. day +365). The percentage usage of antiVEGF agents followed a similar pattern, albeit lower overall usage in patients, with 20% of eyes requiring an antiVEGF in prior 12 months vs. 10% by day +365 post implant (mean injections were 2.1 vs. 2.6, respectively). PostILUVIEN implant, emergent IOPlowering medication was required in 14% of eyes (increasing from 38% at day 365 to 52% at day +365) and there was one case of IOP surgery.
Conclusions: The use of the intravitreal FAc implant in patients with relatively good VA (60 to 70 ETDRS letters) led to marked gains in VA and CFT as well as a reversal of the progressive effects of not responding sufficiently to prior therapies. These findings support the hypothesis being tested that beneficial effects can be achieved with a longacting steroid in patients with established persistent and recurrent DME. It also suggests that identifying patients with good VA may be an effective strategy for optimizing patient outcomes.
This presentation in Euretina was written by Alimera Sciences Limited in consultation with the respective co-authors
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