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Purpose: There has been an increasing clinical interest in specific retinal parameters as non-invasive biomarkers of retinal inflammation in diabetic macular edema (DME) that have been shown to have prognostic value, such as hyperreflective retinal fields (HRFs) and subfoveal neuroretinal detachment (SND). Methods: We conducted a prospective, non-comparative study of treatment-naïve patients with DME to evaluate the efficacy of a Pro Re Nata (PRN) regimen of intravitreal dexamethasone implant 0.7 mg (DexI, Ozurdex™). After administration, patients underwent subsequent injections according to PRN criteria in case of edema relapse, but not earlier than 4 months after the previous treatment. Patients were evaluated at baseline, within 15 days of injection, and every month thereafter. During all visits, best-corrected visual acuity (BCVA) was recorded; central retinal thickness (CRT), type of edema, presence of SND, and presence and number of HRFs were evaluated using swept-source optical coherence tomography (SS-OCT) 3D. Treatment outcome was defined as changes in BCVA, CRT, SND and HRFs at 12 (T12) and 24 (T24) months compared with baseline (T0). Results: The study enrolled 24 eyes of 18 patients. The mean duration of follow-up was 18± 6.6 months; for all eyes, T12 data were available, while follow-up reached T24 for 12 eyes. BCVA improved significantly and CRT decreased significantly during treatment; the edema was no longer detectable in 13/24 eyes at T12 and 8/12 eyes at T24. No patient presented SND at T12 and T24, and the mean number of HRFs decreased significantly during treatment. Results with CRT and HRFs correlated with BCVA at 12 and 24 months. No significant adverse events were observed. Conclusion: In patients with DME, the intravitreal dexamethasone implant was effective and safe in improving both functional and tomographic parameters. This result is consistent with improvement in biomarkers of inflammation. [ABSTRACT FROM AUTHOR]

Background: To evaluate the efficacy and safety of an intravitreal dexamethasone implant (Ozurdex®; Allergan Inc, Irvine, CA, USA) in patients with persistent diabetic macular edema (DME) over a 6-month follow-up period. Methods: Seventeen patients (20 eyes) affected by DME were selected. The mean age was 67 ± 8 years, and the mean duration of DME was 46.3 ± 18.6 months. The eligibility criteria were: age ≥18, a best-corrected visual acuity between 5 and 40 letters, and macular edema with a thickness of ≥275 µm. Thirteen patients had also previously been treated with anti-vascular endothelial growth factor medication. Results: The mean ETDRS (Early Treatment Diabetic Retinopathy Study) value went from 18.80 ± 11.06 (T0) to 26.15 ± 11.03 (P = 0.04), 28.15 ± 10.29 (P = 0.0087), 25.95 ± 10.74 (P = 0.045), 21.25 ± 11.46 (P = 0.5) in month 1, 3, 4, and 6, respectively. The mean logMAR (logarithm of the minimum angle of resolution) value went from 0.67 ± 0.23 (at T0) to 0.525 ± 0.190 (P = 0.03), 0.53 ± 0.20 (P = 0.034), and 0.56 ± 0.22 (P = 0.12) in month 1, 3, and 4, respectively, to finally reach 0.67 ± 0.23 in month 6. The mean central macular thickness value improved from 518.80 ± 224.75 µm (at T0) to 412.75 ± 176.23 µm, 292.0 ± 140.8 µm (P < 0.0001), and 346.95 ± 135.70 (P = 0.0018) on day 3 and in month 1 and 3, respectively, to then increase to 476.55 ± 163.14 µm (P = 0.45) and 494.25 ± 182.70 µm (P = 0.67) in month 4 and 6. Conclusion: The slow-release intravitreal dexamethasone implant, Ozurdex, produced significant improvements in best-corrected visual acuity and central macular thickness from the third day of implant in DME sufferers, and this improvement was sustained until the third month. [ABSTRACT FROM AUTHOR]