A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome
Maria Vadalà,1,2 Valentina Sunseri Trapani,1 Giulia Guarrasi,1 Nicasio Ventura,1 Massimo Castellucci,1 Salvatore Cillino1 1Biomedicine, Neuroscience and Advanced Diagnostic Department, University of Palermo, Palermo, Italy; 2IEMEST, Euro-Mediterranean Institute of Science and Technology,...
Guardado en:
| Autores principales: | , , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Dove Medical Press
2020
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/0df633b46a2245c2b8035d9759a7fbe4 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:0df633b46a2245c2b8035d9759a7fbe4 |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:0df633b46a2245c2b8035d9759a7fbe42021-12-02T11:23:05ZA Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome1177-5483https://doaj.org/article/0df633b46a2245c2b8035d9759a7fbe42020-09-01T00:00:00Zhttps://www.dovepress.com/a-real-world-study-of-dexamethasone-implant-in-treatment-naiumlve-pati-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Maria Vadalà,1,2 Valentina Sunseri Trapani,1 Giulia Guarrasi,1 Nicasio Ventura,1 Massimo Castellucci,1 Salvatore Cillino1 1Biomedicine, Neuroscience and Advanced Diagnostic Department, University of Palermo, Palermo, Italy; 2IEMEST, Euro-Mediterranean Institute of Science and Technology, Palermo, ItalyCorrespondence: Maria VadalàBiomedicine, Neuroscience and Advanced Diagnostic (BIND) Department, Ophthalmology Institute, University of Palermo, Palermo 90127, ItalyTel +39 091 6553909Email maria.vadala@unipa.itPurpose: 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.Keywords: dexamethasone implant, diabetic macular edema, intravitreal implants, Ozurdex, real-world, inflammationVadalà MSunseri Trapani VGuarrasi GVentura NCastellucci MCillino SDove Medical Pressarticledexamethasone implantdiabetic macular edemaintravitreal implantsozurdexreal-worldinflammationOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 2657-2665 (2020) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
dexamethasone implant diabetic macular edema intravitreal implants ozurdex real-world inflammation Ophthalmology RE1-994 |
| spellingShingle |
dexamethasone implant diabetic macular edema intravitreal implants ozurdex real-world inflammation Ophthalmology RE1-994 Vadalà M Sunseri Trapani V Guarrasi G Ventura N Castellucci M Cillino S A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome |
| description |
Maria Vadalà,1,2 Valentina Sunseri Trapani,1 Giulia Guarrasi,1 Nicasio Ventura,1 Massimo Castellucci,1 Salvatore Cillino1 1Biomedicine, Neuroscience and Advanced Diagnostic Department, University of Palermo, Palermo, Italy; 2IEMEST, Euro-Mediterranean Institute of Science and Technology, Palermo, ItalyCorrespondence: Maria VadalàBiomedicine, Neuroscience and Advanced Diagnostic (BIND) Department, Ophthalmology Institute, University of Palermo, Palermo 90127, ItalyTel +39 091 6553909Email maria.vadala@unipa.itPurpose: 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.Keywords: dexamethasone implant, diabetic macular edema, intravitreal implants, Ozurdex, real-world, inflammation |
| format |
article |
| author |
Vadalà M Sunseri Trapani V Guarrasi G Ventura N Castellucci M Cillino S |
| author_facet |
Vadalà M Sunseri Trapani V Guarrasi G Ventura N Castellucci M Cillino S |
| author_sort |
Vadalà M |
| 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 |
| title_short |
A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome |
| title_full |
A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome |
| title_fullStr |
A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome |
| title_full_unstemmed |
A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome |
| title_sort |
real-world study of dexamethasone implant in treatment-naïve patients with diabetic macular edema: efficacy and correlation between inflammatory biomarkers and treatment outcome |
| publisher |
Dove Medical Press |
| publishDate |
2020 |
| url |
https://doaj.org/article/0df633b46a2245c2b8035d9759a7fbe4 |
| work_keys_str_mv |
AT vadalam arealworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT sunseritrapaniv arealworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT guarrasig arealworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT venturan arealworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT castelluccim arealworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT cillinos arealworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT vadalam realworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT sunseritrapaniv realworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT guarrasig realworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT venturan realworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT castelluccim realworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome AT cillinos realworldstudyofdexamethasoneimplantintreatmentnaiumlvepatientswithdiabeticmacularedemaefficacyandcorrelationbetweeninflammatorybiomarkersandtreatmentoutcome |
| _version_ |
1718395921705730048 |