Author: Margarida Brizido (Portugal)
Co-authors: Beatriz Lopes, Ana C. Almeida, Florence Aerts, Pedro Simões, Margarida Miranda
Purpose
Diabetic macular edema (DME) is a major cause of visual impairment in diabetic patients. Current treatments include both anti-VEGF agents and corticosteroid intravitreal injections, as well as thermal laser photocoagulation. The fluocinolone acetonide intravitreal implant (FAc; ILUVIEN®) represents an alternative therapeutic approach, approved for persistent or recurrent DME, with a lower frequency of injections. The aim of this study is to investigate the correlation between systemic factors (metabolic control and comorbidities) and the functional and structural outcomes of the FAc implant injection, based on best corrected visual acuities (BCVA) and central macular thickness (CMT), as measured by optical coherence tomography (OCT).
Setting/Venue
Non-interventional, retrospective, and single-centre analysis performed at the Ophthalmology Department, Hospital Beatriz Ângelo, Loures, Portugal.
Methods
Real-world retrospective study including 22 eyes of 16 patients who received a single FAc implant for refractory or recurrent DME. Patient demographics and ocular baseline characteristics (BCVA [ETDRS letters], CMT [µm], intra-ocular pressure [IOP; mmHg] and previous treatments prior to FAc intravitreal injection) were collected. The authors analysed the following outcomes: baseline and 1-year measurements of BCVA, CFT and IOP and cataract-related events. A correlation analysis was performed, relating effectiveness outcomes and systemic factors, namely glycosylated hemoglobin [HbA1c ≤ 7.5% (good metabolic control), HbA1c higher than 7.5% (poor metabolic control)], arterial hypertension, dyslipidemia, chronic kidney disease, and anemia. Statistical analysis was performed using T-test and non-parametric test of SPSS (version 25.0). The cut-off point for statistical significance was set at p-value lower than 0.05.
Results
Data was collected from 22 eyes of 16 patients (9 males), with a mean age of 71 years (range 64 to 81). Regarding lens status, 12 were phakic (55%). The analyzed population revealed a median(±SD) DME duration of 3.00±1.44 years, with 3 eyes (14%) having proliferative diabetic retinopathy. Before the intervention, 5 eyes (23%) were under IOP-lowering medication. At baseline, median(±SD) HbA1c was 7,65±1,35, with 50% of patients having HbA1c ≤7.5%; 86% were diagnosed with arterial hypertension, 82% with dyslipidemia, 9% with chronic kidney disease and 46% with anemia. The median(±SD) BCVA, CMT and IOP before treatment was 50.00±21.72 ETDRS letters, 491.00±163.81µm and 14.00±4.75mmHg. In the 12 months that followed FAc intravitreal injection, 5 eyes underwent cataract surgery (42% of phakic eyes) and 3 additional eyes received IOP-lowering medication, with final IOP 15.00±6.32mmHg (p=0,2). Functional and structural outcomes globally improved to BCVA 53.00±20.45 ETDRS letters (p=0,2) and CFT 332.00±112.82µm (p=0,0001). Regarding the impact of the systemic factors, at 1-year post-FAc injection, eyes with good metabolic control, without arterial hypertension, dyslipidemia, chronic kidney disease or anemia revealed better functional-structural correlation outcomes: +10 letters (p=0.19)/-323µm (p=0.003); +15letters (p=0.1)/-54µm (p=0.1); +16 letters (p=0.07)/-82.5µm (p=0.07); +7.5 letters (p=0.08)/-217µm (p=0.0002) and +6.5letters (p=0.11)/-210µm (p=0.005), respectively.
Conlusions
Regarding the structural outcomes after treatment, a good metabolic control and the absence of chronic kidney disease or anemia were significantly associated with an improvement in CMT values. Functional outcomes were also better in patients with well-controlled diabetes and without comorbidities, but the difference was not statistically significant between both groups. Overall, the current analysis shows that the efficiency of the FAc intravitreal implant might be influenced by systemic factors, but additional studies with larger sample size are needed to confirm these findings and investigate other demographic and metabolic biomarkers that may help to predict the response to treatment.
Financial Disclosure
The authors acknowledge the support from Alimera Sciences in performing the statistical analysis of the data.
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