Long-Term Intravitreal Dexamethasone Implant Monotherapy in Naïve Patients with Diabetic Macular Edema

Abstract

Objectives: To demonstrate the efficacy and safety of repeated dexamethasone (DEX) implants in eyes with naïve diabetic macular edema (DME) using real-life data over a minimum of 36 months follow-up. Materials and Methods: This retrospective cohort study included treatment-naïve DME patients treated with intravitreal DEX monotherapy and followed for at least 36 months. Main outcomes were best corrected visual acuity (BCVA) and central macular thickness (CMT) change. Secondary outcomes were optical coherence tomography findings, including serous macular detachment, hard exudate, hyperreflective foci, cystoid degeneration, pearl necklace sign, epiretinal membrane (ERM), disorganization of the retinal inner layers (DRIL), ellipsoid zone and external limiting membrane (EZ-ELM) integrity, and intra-cystic hyperreflective material, as well as intraocular pressures and lens status. Results: The study included 74 eyes of 52 patients. The mean follow-up period and number of injections were 49.24±13.51 months and 6.83±2.76, respectively. Both BCVA and CMT improved significantly throughout follow-up (p=0.009; p<0.001). The mean BCVA increased by 7.9±2.1 letters, and 38 patients (51.3%) gained ≥10 letters. Hyperreflective foci (p<0.001), pearl necklace sign (p=0.012), and intra-cystic hyperreflective material (p=0.042) decreased significantly, while ERM (p=0.006), DRIL (p<0.001), and EZ-ELM defects (p<0.001) increased significantly. Conclusion: Intravitreal DEX monotherapy is a safe and effective treatment option for treatment-naïve DME patients in long-term follow-up.