Abstract
Background: The aim of this study was to compare the therapeutic effect of intravitreal treatment with ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers in patients with diabetic macular edema (DME). Methods: 156 treatment-naïve patients with DME were divided in two groups: 75 patients received 3 monthly intravitreal injections of ranibizumab 0.5 mg (Lucentis®) (Group 1) and 81 patients received an intravitreal implant of dexamethasone 0.7 mg (Ozurdex®) (Group 2). Patients were evaluated at baseline (V1), at three months post-treatment in Group 1, and at two months post-treatment in Group 2 (V2). Best-corrected visual acuity (BCVA) and swept source-OCT were recorded at each interval. Changes between V1 and V2 were analyzed using the Wilcoxon test and differences between the two groups of treatment were assessed using the Mann–Whitney test. Multiple regression analysis was performed to evaluate the possible OCT biomarker (CRT, ICR, CT, SND, HRS) as predictive factors for final visual acuity improvement. Results: In both groups, BCVA improved (p-value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed. A superiority of dexamethasone over ranibizumab in reducing the SDN height (p-value = 0.03) and HRS (p-value = 0.01) was documented. Conclusions: Ranibizumab and dexamethasone are effective in the treatment of DME, as demonstrated by functional improvement and morphological biomarker change. DME associated with SDN and HRS represents a specific inflammatory pattern for which dexamethasone appears to be more effective.
Highlights
Fluorescein angiography (FA) and optical coherence tomography (OCT) are the techniques of choice for evaluating diabetic maculopathy, providing several quantitative and qualitative data points concerning diabetic macular edema (DME), which have been extensively used in randomized clinical trials and in clinical practice as non-invasive biomarkers [4]
As first-line therapy, we considered the use of corticosteroids in patients who had a history of a major cardiovascular event, poor compliance to monthly anti-vascular endothelial growth factor (VEGF) treatment, and preferably pseudophakic patients or those without crystalline lens opacity
Numerous studies have been conducted on patients with DME treated with anti-VEGF injections, and it is established that microstructural changes visible at baseline through OCT scans might predict the response to treatment [5,11,12,13,14,15,16]
Summary
Diabetic retinopathy (DR) is the most frequent complication of diabetes and represents one of the leading causes of legal blindness, primarily as a result of diabetic macular edema (DME) [1,2].Diagnostics 2020, 10, 413; doi:10.3390/diagnostics10060413 www.mdpi.com/journal/diagnosticsDME occurs due to an abnormal intra-retinal and eventually sub-retinal fluid collection in the macular area caused by the alteration of the blood retinal barrier and is characterized by pericyte loss and endothelial cell junction breakdown [3].In current practice, fluorescein angiography (FA) and optical coherence tomography (OCT) are the techniques of choice for evaluating diabetic maculopathy, providing several quantitative and qualitative data points concerning DME, which have been extensively used in randomized clinical trials and in clinical practice as non-invasive biomarkers [4].In particular, central retinal thickness (CRT), the presence of hyper-reflective spot (HRS), serous detachment of neuro-epithelium (SDN), the size of intra-retinal cysts (IRC), the occurrence of disorganization of the inner retinal layers (DRIL), the state of the ellipsoid zone (EZ), the external limiting membrane (ELM), as well as the choroidal thickness (CT) have been used to characterize DME [4,5,6,7,8].Recent animal and clinical studies strongly suggest a central inflammatory role in DME. Fluorescein angiography (FA) and optical coherence tomography (OCT) are the techniques of choice for evaluating diabetic maculopathy, providing several quantitative and qualitative data points concerning DME, which have been extensively used in randomized clinical trials and in clinical practice as non-invasive biomarkers [4]. SDN and HRS have been recently proposed as non-invasive OCT-imaging biomarkers of retinal inflammation in DME [11]. The aim of this study was to compare the therapeutic effect of intravitreal treatment with ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers in patients with diabetic macular edema (DME). Multiple regression analysis was performed to evaluate the possible OCT biomarker (CRT, ICR, CT, SND, HRS)
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