Author: João Romano (Portugal)
Co-authors: Maria J. Vieira, Joana Martins, Nuno Oliveira, António Campos, João P. Sousa
Purpose
Spectral domain optical coherence tomography (SD-OCT) technology led to an advanced knowledge of the structural alterations that happen in macular diseases, while offering a method of assessing quantitatively the outcomes of treatments on retinal thickness and volume. In this regard, the aim of this study was 1) to evaluate the anatomic effectiveness and safety outcomes after treatment with 0.19mg fluocinolone acetonide intravitreal implant (FAc; ILUVIEN®) in patients diagnosed with persistent and/or recurrent diabetic macular edema; and 2) to compare outcomes between vitrectomized eyes at baseline versus non-vitrectomized.
Setting/Venue
Non-interventional, retrospective, and single center real-world analysis conducted at the Ophthalmology Department, Centro Hospitalar de Leiria - Hospital Santo André, Leiria, Portugal.
Methods
A total of 56 eyes of 43 patients were treated with 0.19 mg FAc intravitreal implant for persistent/recurrent DME following an insufficient response to previous treatments (persistent/recurrent macular edema). The mean follow-up period was 15±8 months (mean±standard deviation) (range, 1 to 31 months) for the full population, and for vitrectomized (group 1, n=20) and non-vitrectomized eyes (group 2, n=36) was 16±3 months (range, 3 to 31 months) and 14±7 months (range, 1 to 27 months), respectively (p=0.27 between group 1 and 2). Standard measures included: central macular thickness (CMT; µm), macular volume (MV; mm3), best-corrected visual acuity (BCVA; ETDRS letters score), intraocular pressure (IOP; mmHg), IOP related events and presence of prior treatments. All parameters were assessed at baseline, and months 1 and 3, and then quarterly afterwards; all results are also reported at last observation. T-test, non-parametric and Fisher's exact Chi-squared tests were performed using SPSS (version 25.0); statistical significance was taken as p-value<0.05.
Results
At baseline, the mean duration of DME was 5±2 years for the full population and 36% had prior vitrectomy. After FAc injection, the mean reduction of CMT/VM was -162µm/2mm3 for the full population (CMT/VM p<0.001/p<0.001 vs baseline), and for group 1 and 2 the median reduction was -198µm/2mm3 and -177µm/2mm3 (group 1 vs 2 CMT/MV p=0.76/p=0.37), respectively. All of the groups (full data and comparative data) showed a CMT reduction >20% and a stabilized or improved BCVA at last observation. Safety outcomes revealed a mean increase in IOP at last observation of +2mmHg for full population (p=0.01 vs baseline); at baseline 3 eyes were prior diagnosed of glaucoma, 36% of the remaining eyes were stabilized with IOP-lowering medication. Regarding vitrectomized versus non-vitrectomized groups, showed similar numerical trend for the percentage of eyes with IOP-lowering drops at last observation (40% group 1 vs 33% group 2, p=0.41) and similar trend for IOP rise (+0.2mmHg group 1 vs +0.8mmHg group 2, p=0.66).
Conlusions
This clinical practice study determines the anatomic benefit, for both full population and comparison analysis - vitrectomized versus non-vitrectomized eyes -, with the treatment with FAc implant after an insufficient response to previous treatments. Moreover, this analysis reinforces ILUVIEN® effectiveness and safety profile and is comparable with others ILUVIEN® real-world data. Still, monitoring stays essential in patients treated with the FAc intravitreal implant, mainly if is injected considering risk/benefit (patients with prior diagnosed with intraocular hypertension and glaucoma).
Financial Disclosure
No financial conflicts of interest.
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