Describing Patient With DME, Their Patient Journey and Disease Progression
Observational Study on the Management, and Progression of Patients With Diabetic Macula Edema (DME)
1 other identifier
observational
221,004
1 country
1
Brief Summary
This study aims to characterize patients with diabetic macular edema (DME), their progression, the treatment received and associate the functional and physiological outcomes related to the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
August 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 19, 2024
December 1, 2024
5 months
July 21, 2023
December 17, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Change in visual acuity
From January 2015 to April 2023
Progression to DME in the fellow eye
From January 2015 to April 2023
Initial treatment of DME
From January 2015 to April 2023
Central retinal thickness (CRT)
From January 2015 to April 2023
Study Arms (1)
Patients with diabetic macula edema (DME)
Patients diagnosed with diabetic macula edema (DME) in at least one eye, at least 18 years old, with information on laterality and registered in the Vestrum health database between January 2015 and May 2023.
Eligibility Criteria
The study population is based on the patients attending a retinal specialist, included in the Vestrum Retinal specialist database. The study population will include adult patients with a DME diagnosis in at least one eye.
You may qualify if:
- All patients ≥18 years, with a DME diagnosis in at least one eye, included in the Vestrum database identified during the study period (January 2015 to April 2023)
You may not qualify if:
- Patients without the information of laterality will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CorEvitas HQ
Waltham, Massachusetts, 02451, United States
Related Links
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2023
First Posted
August 1, 2023
Study Start
August 3, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
December 19, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency