Clinical trial NCT05891275: Patients With Geographic Atrophy and Their Patient Journey in the United States (US)
Official title: Characterization of Patients With Geographic Atrophy (GA) in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geographic Atrophy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 68563
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US patients ≥50 years, with a Geographic Atrophy diagnosis in at least one eye

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Visual Acuity (VA) in Participant's Study Eye
timeFrame: From index date of GA diagnosis up to 5 years
measure: Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye
timeFrame: From index date of GA diagnosis up to 5 years.
measure: Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye
timeFrame: From index date of GA diagnosis up to 5 years.
measure: Change in Lesion Location for Participants With wAMD in Study Eye
timeFrame: From index date of GA diagnosis up to 5 years
measure: Change in Lesion Location for Participants With GA in Fellow Eye
timeFrame: From index date of GA diagnosis up to 5 years
measure: Occurrence of GA Over Study Period
timeFrame: Number of yearly counts of GA from 2018 to 2013, by quarterly average.
Secondary outcomes:
measure: Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year
timeFrame: Mean number of quarterly visits from 2019 up to 2023.
measure: Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter
timeFrame: Mean number of quarterly anti-VEGF injections from 2019 up to 2023.
measure: Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up
timeFrame: Total number of participants with ocular comorbidities were documented from index date up to 5 years.
measure: HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant
timeFrame: Total number of participants with corneal transplants were documented from index date up to 5 years.
measure: HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery
timeFrame: Total number of participants with incisional glaucoma surgery were documented from index date up to 5 years.
measure: HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy
timeFrame: Total number of participants with vitrectomy were documented from index date up to 5 years.
Other outcomes:
Locations:
city: Waltham
country: United States
facility: CorEvitas HQ
state: Massachusetts
Study officials:
References: