Intravitreal dexamethasone implant one month before versus concomitant with cataract surgery in patients with diabetic macular oedema: the dexcat study.

PURPOSE: To report clinical outcomes of two different timings of intravitreal dexamethasone (DEX) implant administration for prevention of diabetic macular oedema (DME) worsening following cataract surgery. METHODS: This multicentre, retrospective study included patients with DME who received an intravitreal DEX implant 1 month before cataract surgery, 'precataract DEX' group, or at the time of cataract surgery, 'concomitant treatments' group. Inclusion criteria were a follow-up ≥3 months and ophthalmological examination with optical coherence tomography (OCT) imaging at baseline (cataract surgery) and throughout follow-up. Anatomical improvement was considered to be a decrease in OCT central subfield (CSF) thickness ≥20% compared to baseline. The primary outcomes were anatomical and functional results at 3 months. RESULTS: Two hundred twenty-one patients were included: 136 in the 'precataract DEX' group and 85 in the 'concomitant treatments' group. At 3 months, a reduction of CSF thickness ≥ 20% was found in 7.3% of eyes in the 'precataract DEX group' and in 83.7% of eyes in the 'concomitant treatments' group (p < 0.001), with mean CSF thickness lower in the latter group (371 ± 52 µm versus 325 ± 57 µm, p < 0.001). At 3 months, mean best-corrected visual acuity had improved from baseline in both groups (p < 0.001), with no difference between groups (p = 0. 20). No serious systemic adverse events were reported. CONCLUSION: Both approaches prevented a worsening of DME, showing a comparable visual outcome. Dexamethasone (DEX) implant given at the same time as cataract surgery provided a better anatomical outcome.

A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome.

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.