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

Clinical ophthalmology (Auckland, N.Z.), 2020-01, Vol.14, p.2657-2665 [Peer Reviewed Journal]

2020 Vadalà et al. ;COPYRIGHT 2020 Dove Medical Press Limited ;COPYRIGHT 2020 Dove Medical Press Limited ;2020. This work is licensed under https://creativecommons.org/licenses/by-nc/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;2020 Vadalà et al. 2020 Vadalà et al. ;ISSN: 1177-5467 ;ISSN: 1177-5483 ;EISSN: 1177-5483 ;DOI: 10.2147/OPTH.S257775 ;PMID: 32982158

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  • Title:
    A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome
  • Author: Vadalà, Maria ; Sunseri Trapani, Valentina ; Guarrasi, Giulia ; Ventura, Nicasio ; Castellucci, Massimo ; Cillino, Salvatore
  • Subjects: Biological markers ; Biomarkers ; Care and treatment ; Central nervous system depressants ; Comparative analysis ; Dexamethasone ; dexamethasone implant ; Diabetes ; diabetic macular edema ; Diabetic retinopathy ; Dropsy ; Drug delivery systems ; Edema ; FDA approval ; Fluocinolone ; Fluocinolone acetonide ; Glaucoma ; Hypertension ; Inflammation ; intravitreal implants ; Medical research ; Medicine, Experimental ; Original Research ; ozurdex ; Patient outcomes ; real-world ; Software ; Transplants & implants
  • Is Part Of: Clinical ophthalmology (Auckland, N.Z.), 2020-01, Vol.14, p.2657-2665
  • Description: 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). 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). 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. 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.
  • Publisher: New Zealand: Dove Medical Press Limited
  • Language: English
  • Identifier: ISSN: 1177-5467
    ISSN: 1177-5483
    EISSN: 1177-5483
    DOI: 10.2147/OPTH.S257775
    PMID: 32982158
  • Source: DOAJ Directory of Open Access Journals
    GFMER Free Medical Journals
    PubMed Central
    DOVE Medical Press Journals
    ProQuest Central
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