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Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.
The ESASO morphologic classification of diabetic macular edema defines four stages of progression of the disease: early, advanced, chronic and atrophic maculopathy.
This grading is generated by the analysis of seven biomarkers that fully describe the level of retinal damage. Aim of this classification is to be a valid method for a comprehensive description of DME in scientific studies or clinical practice.
Given the recent publication of ESASO Classification, there aren't observations on the real relevance of grading DME on therapeutic outcome.
This retrospective study wants to give a preliminary answer to this important issue.
As a corollary outcome, this study will also evaluate the concordance of grading among participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early DME | Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately |
| |
| Advanced DME | Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately |
| |
| Severe DME | Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately |
| |
| Atrophic diabetic maculopathy | Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone | Drug | intravitreal administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease. | Visual acuity and morphological (OCT) stage of the disease (as described in ESASO DME classification) will be evaluated at time 0 and four months after the first injection of intravitreal dexamethasone or one month after the loading phase (3 monthly injections) with anti-VEGF. | Four months |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of ESASO DME staging classification | After preliminary instruction on ESASO Staging system of DME, participating centers will evaluate the stage of DME at time 0 of every eye retrospectically selected to participate to the study. This staging will be than validated by the Coordinating Center, and the total concordance of staging (K index) will be used to validate the Classification | 3 months |
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Inclusion Criteria. Eligible eyes at the retrospective review
Exclusion Criteria:
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B. Major Eligibility Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ESASO Scientific Projects | Lugano | CH-6901 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31718271 | Background | Panozzo G, Cicinelli MV, Augustin AJ, Battaglia Parodi M, Cunha-Vaz J, Guarnaccia G, Kodjikian L, Jampol LM, Junemann A, Lanzetta P, Lowenstein A, Midena E, Navarro R, Querques G, Ricci F, Schmidt-Erfurth U, Silva RMD, Sivaprasad S, Varano M, Virgili G, Bandello F. An optical coherence tomography-based grading of diabetic maculopathy proposed by an international expert panel: The European School for Advanced Studies in Ophthalmology classification. Eur J Ophthalmol. 2020 Jan;30(1):8-18. doi: 10.1177/1120672119880394. Epub 2019 Nov 12. | |
| 34345028 |
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| Background |
| Panozzo G, Mura GD, Franzolin E, Giannarelli D, Albano V, Alessio G, Arrigo A, Casati S, Cassottana P, Contardi C, D'Aloisio R, Fasce F, Gusson E, Marchini G, Mastropasqua L, Niccolo M, Palmisano C, Pastore MR, Saviano S, Tognetto D, Bandello F. Early DMO: a predictor of poor outcomes following cataract surgery in diabetic patients. The DICAT-II study. Eye (Lond). 2022 Aug;36(8):1687-1693. doi: 10.1038/s41433-021-01718-4. Epub 2021 Aug 3. |