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Describing Patient With DME, Their Patient Journey and Disease Progression

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05966753
Collaborator
(none)
182,000
Enrollment
2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    182000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Observational Study on the Management, and Progression of Patients With Diabetic Macula Edema (DME)
    Anticipated Study Start Date :
    Jul 31, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with Diabetic macular edema cohort

    Outcome Measures

    Primary Outcome Measures

    1. Change in visual acuity [From January 2015 to April 2023]

    2. Progression to DME in the fellow eye [From January 2015 to April 2023]

    3. Initial treatment of DME [From January 2015 to April 2023]

    4. Central retinal thickness (CRT) [From January 2015 to April 2023]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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)

    Exclusion Criteria:

    Patients without the information of laterality will be excluded.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT05966753
    Other Study ID Numbers:
    • 1485-0016
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Edema

    Study Results

    No Results Posted as of Aug 1, 2023