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OpenTrials
Completed

NCT Number: NCT05891275

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

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Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CorEvitas HQ

Waltham, Massachusetts, 02451, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: From index date of GA diagnosis up to 5 years

    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.

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

    Time frame: 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 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.

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

    Time frame: 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 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.

  4. Change in Lesion Location for Participants With wAMD in Study Eye

    Time frame: From index date of GA diagnosis up to 5 years

    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.

  5. Change in Lesion Location for Participants With GA in Fellow Eye

    Time frame: From index date of GA diagnosis up to 5 years

    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.

  6. Occurrence of GA Over Study Period

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

    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.

Secondary outcomes

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

    Time frame: Mean number of quarterly visits from 2019 up to 2023.

    The retinal disease-related healthcare resource utilization (HCRU) outcome, number of visits by participants per quarter in a year is reported.

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

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

    The retinal disease-related healthcare resource utilization (HCRU) outcome, number of anti-vascular endothelial growth factor (anti-VEGF) injections per quarter in a year is reported.

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

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

    The retinal disease-related HCRU outcome, number of ocular comorbidities by year of follow up is reported.

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

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

    The number of participants with corneal transplant during the observational period is reported.

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

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

    Number of participants with incisional glaucoma surgery during the observational period is reported.

  6. HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy

    Time frame: Total number of participants with vitrectomy were documented from index date up to 5 years.

    Number of participants with vitrectomy during the observational period is reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2023
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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