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Patients With Geographic Atrophy and Their Patient Journey in the United States (US)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05891275
Collaborator
(none)
70,000
Enrollment
2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To quantify and describe patients with a Geographic Atrophy (GA) diagnosis in at least one eye, and the progression to neovascular Age-Related Macular Degeneration (including how many receive Anti-VEGF), or to GA (in the fellow eye only).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Characterization of Patients With Geographic Atrophy (GA) in the US
    Anticipated Study Start Date :
    May 31, 2023
    Anticipated Primary Completion Date :
    Jul 31, 2023
    Anticipated Study Completion Date :
    Jul 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with a Geographic Atrophy diagnosis

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of developing of Neovascular Age-Related Macular Degeneration (wAMD) [Up to the 5th year of the follow-up period.]

    2. Changes in the Geographic Atrophy (GA) lesion location [Up to the 5th year of the follow-up period.]

    3. Changes in the Visual Acuity (VA) [Up to the 5th year of the follow-up period.]

    4. Changes in the size of the GA lesion [Up to the 5th year of the follow-up period.]

    5. Occurrence of developing of GA [Up to the 5th year of the follow-up period.]

    6. Occurrence of patients with a newly diagnosis of GA [Up to the 5th year of the follow-up period.]

    7. Prevalence of GA [Up to the 5th year of the follow-up period.]

    Secondary Outcome Measures

    1. Retinal Disease Related health care resource utilization ((HCRU) Outcome:Occurrence of patients visits [Up to the 5th year of the follow-up period.]

    2. Retinal Disease Related HCRU Outcomes: Occurrence of medical procedures [Up to the 5th year of the follow-up period.]

      Medical procedures include for example, checkups, cataracts removal, eye lid (ptosis correction), etc.

    3. Occurrence of ocular comorbidities [Up to the 5th year of the follow-up period.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients ≥50 years, with a GA 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:
    NCT05891275
    Other Study ID Numbers:
    • 1484-0014
    First Posted:
    Jun 6, 2023
    Last Update Posted:
    Jun 6, 2023
    Last Verified:
    May 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:
    Geographic Atrophy
    Atrophy

    Study Results

    No Results Posted as of Jun 6, 2023