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

February 8, 2024 updated by: Boehringer Ingelheim

Characterization of Patients With Geographic Atrophy (GA) in the US

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

68563

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • CorEvitas HQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

US patients ≥50 years, with a Geographic Atrophy diagnosis in at least one eye

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with a Geographic Atrophy diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of developing of Neovascular Age-Related Macular Degeneration (wAMD)
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.
Changes in the Geographic Atrophy (GA) lesion location
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.
Changes in the Visual Acuity (VA)
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.
Changes in the size of the GA lesion
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.
Occurrence of developing of GA
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.
Occurrence of patients with a newly diagnosis of GA
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.
Prevalence of GA
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Disease Related health care resource utilization ((HCRU) Outcome:Occurrence of patients visits
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.
Retinal Disease Related HCRU Outcomes: Occurrence of medical procedures
Time Frame: Up to the 5th year of the follow-up period.
Medical procedures include for example, checkups, cataracts removal, eye lid (ptosis correction), etc.
Up to the 5th year of the follow-up period.
Occurrence of ocular comorbidities
Time Frame: Up to the 5th year of the follow-up period.
Up to the 5th year of the follow-up period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1484-0014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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