Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-01 @ 1:23 AM
Study NCT ID:
NCT05080803
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
Sponsor:
European School of Advanced Studies in Ophthalmology
Organization:
Study Overview
Official Title:
Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: