Abstract
Purpose Inflammation plays a key role in the pathogenesis of diabetic macular edema (DME), and intravitreal corticosteroids are among the recommended therapies. The goal of this retrospective analysis was to describe outcomes with dexamethasone intravitreal implant (DEX implant) in real life. Methods Medical digital records of DME patients treated with DEX implant and followed up for 3 years were analyzed. Treatment with DEX implant was started either as first-line therapy in pseudophakic patients and in patients with cardiovascular comorbidities or as second-line therapy in patients refractory to the inhibitor of the vascular endothelial growth factor (anti-VEGF) therapy. Analyzed outcomes included central macular thickness (CMT) and best-corrected visual acuity (BCVA). Mean number of implant injections per patient and mean duration of the interval between injections were also estimated. Results Seventy-five patients (mean age 65.7 (±12.3) years; 53 phakic and 22 pseudophakic) with DME were included. Overall, 84 eyes were treated. Mean CMT improved from 380.1 (±100.3) µm at baseline to 306.8 (±77.0) µm at 36 months (p=0.0003). Mean BCVA improved for up to 6 months (p=0.08) and then started to decrease reaching values lower than baseline after 24 months. In pseudophakic patients, BCVA improvements were more pronounced and sustained up to 36 months (p=0.6). Over 36 months, each patient received on average 2.4 (±1.6) intravitreal injections of DEX implant. The time interval between consecutive injections was included between 180 and 240 days. No unexpected safety issues were reported. Conclusions With fewer than 3 injections per patient over a 3-year period, DEX implant was able to improve anatomic outcomes in DME patients. Only pseudophakic eyes showed also a long lasting functional benefit at 36 months.
Highlights
Diabetic macular edema (DME) is characterized by the accumulation of fluid within the central portion of the retina and by macular thickening caused by blood-retinal barrier dysfunction [1]
Anti-vascular endothelial growth factor (VEGF) agents are administered by intravitreal injection on a monthly basis, which may represent a considerable burden for many patients
Anti-VEGF agents are not indicated for DME patients with a history of major cardiovascular events [1]. erefore, there is a need for additional approaches to the treatment of DME [3]
Summary
Diabetic macular edema (DME) is characterized by the accumulation of fluid within the central portion of the retina and by macular thickening caused by blood-retinal barrier dysfunction [1]. DME, which results in reduced visual acuity and is a major cause of visual loss, is estimated to affect approximately one-fifth of patients with diabetic retinopathy [1,2,3]. Anti-VEGF agents have since rapidly emerged as first-line therapy for DME [1]. Journal of Ophthalmology evidence from trials, as well as from real-life observational studies, has shown that significant proportions of DME patients have an incomplete response or fail to respond to anti-VEGF therapy [1, 8]. Anti-VEGF agents are not indicated for DME patients with a history of major cardiovascular events [1]. Anti-VEGF agents are not indicated for DME patients with a history of major cardiovascular events [1]. erefore, there is a need for additional approaches to the treatment of DME [3]
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