Author: Miguel Afonso (Portugal)
Co-authors: João Leite, André Ferreira, João Coelho, Tânia Borges, Nuno Correia, Bernardete Pessoa
Purpose
The ILUVIEN® implant (fluocinolone acetonide, FAc 0.19 mg), due to its unique sustained micro-dosing technology allows treating diabetic macular edema (DME) continuously, up to 36 months. In Europe, it is indicated for the treatment of persistent and recurrent Diabetic Macular Edema (DME) considered insufficiently responsive to first-line therapies. According to the IRISS study, patients with chronic short-term DME, injected with ILUVIEN® implant, achieved greater visual gains compared to patients with long-term chronic DME. The purpose of this study is to determine the degree of functional and anatomical improvement considering the chronicity of edema following ILUVIEN® implant.
Setting/Venue
This study evaluates the functional and anatomical improvement considering the chronicity of edema following ILUVIEN® implant, performed at Centro Hospitalar e Universitário do Porto, Portugal.
Methods
This is a retrospective and comparative analysis of 34 eyes of 28 patients diagnosed with DME who were treated with ILUVIEN® implant after an insufficient response to previous treatments. The eyes were divided into 2 groups according to the duration of edema: ≤3 years, i.e. short-term edema (group 1; n = 18) and> 3 years, i.e. long-term edema (group 2; n = 16). Best Corrected Visual Acuity (BCVA) reported in ETDRS letters, number of previous intravitreal anti-VEGF and short-acting steroids, duration of edema and Intra-Ocular Pressure (IOP) as well as assessment of Central Macular Thickness (CMT), by Spectral Domain Optical Coherence Tomography (SD-OCT) were recorded at baseline. The results reflect the mean variations in BCVA, CMT and IOP, recorded at month 1, 3 and then every 3 months up to 3 years.
Results
At baseline, the mean age of group 1 was 68.9 ± 7.2 years and of group 2 69.9 ± 8.5 years (p>0.5); the mean duration of DME was 2.6 ± 0.4 months in group 1 and 4.5 ± 0.9 months in group 2 (p<0.001). The mean follow-up for groups 1 and 2 was 32.8 ± 3.6 and 32.1 ± 5.6 months, respectively (p>0.5). Prior to ILUVIEN®, all eyes received intravitreal injections of anti-VEGF (group 1: 2.9 ± 1.6 injections and group 2: 5.4 ± 3.6 injections (p<0.01) and / or short-acting steroids (group 1: 2.6 ± 4.0 injections and group 2: 4.0 ± 4.5 injections (p > 0.5). Mean BCVA, in group 1 increased 13.7 ETDRS letters at last observation and in group 2, mean BVCA increased 6.9 ETDRS letters at last observation (p< 0.05). CMT decreased by 248.3 μm in group 1 and by 201.8 μm in group 2 (p>0.5), from baseline to last observation. IOP remained stable and without significant variations over 36 months, in both groups (p>0.5).
Conlusions
This study not only demonstrated greater visual gains in patients with less chronic DME - which is in line with the IRISS study results - but also revealed superior morphological results in this group of patients, with increased edema reduction although without statistical significance. As such, this analysis once again highlights the clinically significant anatomical response to ILUVIEN® and functional benefit of early treatment with ILUVIEN® in eyes with persistent and recurrent diabetic macular edema.
Financial Disclosure
The authors don´t have any financial relations with specific companies.
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