Efficacy and Safety of a Dexamethasone Implant in Patients with Diabetic Macular Edema at Tertiary Centers in Korea

Abstract

Purpose. To evaluate the real-world efficacy and safety of the dexamethasone implant (DEX implant) in patients with diabetic macular edema (DME). Methods. Retrospective, multicenter, and noncomparative study of DME patients who were treated with at least one DEX implant. A total of 186 eyes from 165 patients were included. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), complications, and number of retreatments were collected. Data at baseline and monthly for 6 months were analyzed. Results. The average baseline BCVA and CRT were 0.60 LogMAR and 491.6 μm, respectively. The mean BCVA improved until 3 months and then decreased up to 6 months of follow-up (0.53, 0.49, and 0.55 LogMAR at 1, 3, and 6 months; p = 0.001, <0.001, and 0.044, resp.). The change of mean CRT was similar to BCVA (345.0, 357.7, and 412.5 μm at 1, 3, and 6 months, p < 0.001, <0.001, and <0.001, resp.). 91 eyes (48.9%) received additional treatment with anti-VEGF or DEX implant. The average treatment-free interval was 4.4 months. In group analyses, the DEX implant was more effective in pseudophakic eyes, DME with subretinal fluid (SRF), or diffuse type. Conclusions. Intravitreal dexamethasone implants are an effective treatment for patients with DME, most notably in pseudophakic eyes, DME with SRF, or diffuse type. A half of these patients require additional treatment within 6 months.

Real-World Assessment of Dexamethasone Intravitreal Implant in DME: Findings of the Prospective, Multicenter REINFORCE Study

“…Another real-world study conducted in Korea found that in patients with DME, DEX improved mean BCVA from 0.60 logMAR at baseline to 0.49 logMAR at 3 months and 0.55 log-MAR at 6 months (mean improvement of 6 and 3 approximate ETDRS letters, respectively), and the mean CRT improved from 491.6 µm at baseline to 357.7 µm at 3 months and 412.5 µm at 6 months. 14 Consistent with the present study, 48.9% of patients received additional treatment with intravitreal anti-VEGF therapy or a second DEX injection within 6 months, and the mean treatment-free interval was 4.4 months after the first DEX injection. Finally, in a real-world study of the dosing regimens of DEX used for DME treatment in France, the mean DEX injection interval was 4.9 months, with an average of 2.4 injections administered per year for patients with DME.…”

Association Between Hyperreflective Dots on Spectral-Domain Optical Coherence Tomography in Macular Edema and Response to Treatment

“…41 Therefore, inhibiting inflammatory pathway mediators could be one of the therapeutic options for the ME and the use of intravitreal steroid therapy, including the dexamethasone implant, has been increasingly used for the treatment of ME in DR and RVO patients. [4][5][6][7]42,43 In a patient with ME, a certain mechanism (VEGF pathway or inflammatory pathway) might contribute more to the development of ME. This eventually affects the treatment response to a certain treatment modality.…”

“…3 Various treatments, such as intravitreal anti-VEGF injections and intravitreal dexamethasone injections have shown good visual and anatomic outcomes. [4][5][6][7][8][9][10][11][12][13] However, some ME cases show suboptimal response to these treatment modalities.…”

Differential response to intravitreal dexamethasone implant in naïve and previously treated diabetic macular edema eyes

“…Other real-life studies have also shown similar improvements in VA and CRT without serious adverse events, mainly in smaller series over shorter follow-up periods. [31][32][33][34][35][36] In our population of DME patients, IDI considerably improved the VA relative to baseline in both treatment-naive and previously treated patients, suggesting that IDI therapy offers bene ts to both types of patient. Nevertheless, naive eyes maintained a better mean VA than previously treated eyes at all time points studied.…”