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

NCT05891275 | Completed Results

• 1 other identifier: 1484-0014
• Study Type: observational
• Target: 68,563
• Locations: 1 country
• Sites: 1

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).

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (6)

• Change in Visual Acuity (VA) in Participant's Study Eye

  Change in visual acuity (VA) in participant's study eye is reported. Study eye is defined as the first eye with the disease, and fellow eye, the participant's second eye. Change in VA was determined by calculating the difference between mean visual acuity (VA) readings at index diagnosis, and mean at another timepoint, assessed yearly for participants with valid VA readings at both timepoints.

  From index date of GA diagnosis up to 5 years

• Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye

  Number of participants who developed or progressed to age-related macular degeneration (wAMD) in the study eye is reported. The criteria used to determine progression through development to wAMD was identifying when ICD (International Classification of Diseases) codes for wAMD were present in the study eye.

  From index date of GA diagnosis up to 5 years.

• Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye

  Number of participants who developed or progressed to geographic atrophy (GA) in the fellow eye is reported. For patients diagnosed with GA at baseline, the development of GA in the fellow eye was closely monitored over time, with progress tracked for each year.

  From index date of GA diagnosis up to 5 years.

• Change in Lesion Location for Participants With wAMD in Study Eye

  Change in lesion location from extrafoveal to subfoveal in participants who developed wAMD in study eye is reported. Lesion location was assessed at index diagnosis and at each year, then stratified by whether a patient developed wAMD in the 5 years post diagnosis. Changes in lesion were calculated as the difference in the number of participants with extrafoveal location at index diagnosis of the study eye, compared to the number of participants with extrafoveal lesion in the study eye at each year.

  From index date of GA diagnosis up to 5 years

• Change in Lesion Location for Participants With GA in Fellow Eye

  Change in lesion location from extrafoveal to subfoveal in participants who developed GA in fellow eye is reported. Lesion location was assessed at index diagnosis and at each year, then stratified by whether a patient developed GA in the 5 years post diagnosis. Changes in lesion were calculated as the difference in the number of participants with extrafoveal location at index diagnosis of the study eye, compared to the number of participants with extrafoveal lesion in the study eye at each year.

  From index date of GA diagnosis up to 5 years

• Occurrence of GA Over Study Period

  Incidence and prevalence of GA over time is reported. This endpoint analyzed the yearly counts of newly diagnosed or prevalent cases to help in understanding the progression of the overall disease.

  Number of yearly counts of GA from 2018 to 2013, by quarterly average.

Secondary Outcomes (6)

• Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year

  Mean number of quarterly visits from 2019 up to 2023.

• Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter

  Mean number of quarterly anti-VEGF injections from 2019 up to 2023.

• Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up

  Total number of participants with ocular comorbidities were documented from index date up to 5 years.

• HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant

  Total number of participants with corneal transplants were documented from index date up to 5 years.

• HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery

  Total number of participants with incisional glaucoma surgery were documented from index date up to 5 years.

Study Arms (1)

Patients with a Geographic Atrophy diagnosis

Patients diagnosed with geographic atrophy (GA) in at least one eye, at least 50 years old with information on laterality, and registered in the Vestrum health database between January 2015 and April 2023.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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).

You may not qualify if:

• \- Patients without the information of laterality will be excluded.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CorEvitas HQ

Waltham, Massachusetts, 02451, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

The Vestrum database used in this study included only data from visits that occurred at the practices contributing to the database, therefore anything occurring during visits to a retinal specialist in a different practice, state, country etc. was not captured. An overall limitation of the dataset is that data is typically entered by the physician, therefore there is no real-time validation of the information entered during the encounter either in terms of completeness or accuracy.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: May 31, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)