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NCT05891275

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

Completed Results posted Last updated 1 May 2025
What this trial tests

trial in Geographic Atrophy in 68,563 participants. Completed in 1 December 2023.

Timeline
31 May 2023
Primary endpoint
1 December 2023
1 December 2023

Quick facts

Lead sponsorBoehringer Ingelheim
StatusCompleted
Study typeOBSERVATIONAL
Enrollment68,563
Start date31 May 2023
Primary completion1 December 2023
Estimated completion1 December 2023
Sites1 location across United States

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

50 and older, any sex, with Geographic Atrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Change in VA (Year 1)
GroupValue95% CI
Patients With Geographic Atrophy (GA)-2.8-3.0 – -2.6
Change in VA (Year 2)
GroupValue95% CI
Patients With Geographic Atrophy (GA)-5.9-6.2 – -5.6
Change in VA (Year 3)
GroupValue95% CI
Patients With Geographic Atrophy (GA)-8.6-9.0 – -8.2
Change in VA (Year 4)
GroupValue95% CI
Patients With Geographic Atrophy (GA)-10.3-10.9 – -9.8
Change in VA (Year 5)
GroupValue95% CI
Patients With Geographic Atrophy (GA)-11.9-12.6 – -11.2
Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye Primary · 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.

Participants with wAMD in 1+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)1866
Participants with wAMD in 2+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)2271
Participants with wAMD in 3+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)2191
Participants with wAMD in 4+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)1764
Participants with wAMD in 5+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)1247
Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye Primary · 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.

Participants with GA in fellow eye in 1+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)1102
Participants with GA in fellow eye in 2+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)1319
Participants with GA in fellow eye in 3+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)1207
Participants with GA in fellow eye in 4+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)936
Participants with GA in fellow eye in 5+ years
GroupValue95% CI
Patients With Geographic Atrophy (GA)635
Change in Lesion Location for Participants With wAMD in Study Eye Primary · 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.

Participants with change of lesion location in Year 1
GroupValue95% CI
Patients With Geographic Atrophy (GA)9
Participants with change of lesion location in Year 2
GroupValue95% CI
Patients With Geographic Atrophy (GA)26
Participants with change of lesion location in Year 3
GroupValue95% CI
Patients With Geographic Atrophy (GA)28
Participants with change of lesion location in Year 4
GroupValue95% CI
Patients With Geographic Atrophy (GA)31
Participants with change of lesion location in Year 5
GroupValue95% CI
Patients With Geographic Atrophy (GA)44
Change in Lesion Location for Participants With GA in Fellow Eye Primary · 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.

Participants with change of lesion location in Year 1
GroupValue95% CI
Patients With Geographic Atrophy (GA)27
Participants with change of lesion location in Year 2
GroupValue95% CI
Patients With Geographic Atrophy (GA)41
Participants with change of lesion location in Year 3
GroupValue95% CI
Patients With Geographic Atrophy (GA)59
Participants with change of lesion location in Year 4
GroupValue95% CI
Patients With Geographic Atrophy (GA)67
Participants with change of lesion location in Year 5
GroupValue95% CI
Patients With Geographic Atrophy (GA)89
Occurrence of GA Over Study Period Primary · 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.

Total new diagnosis of GA patients by quarterly average in 2018
GroupValue95% CI
Patients With Geographic Atrophy (GA)2208
Total new diagnosis of GA patients by quarterly average in 2019
GroupValue95% CI
Patients With Geographic Atrophy (GA)2227
Total new diagnosis of GA patients by quarterly average in 2020
GroupValue95% CI
Patients With Geographic Atrophy (GA)1881
Total new diagnosis of GA patients by quarterly average in 2021
GroupValue95% CI
Patients With Geographic Atrophy (GA)2273
Total new diagnosis of GA patients by quarterly average in 2022
GroupValue95% CI
Patients With Geographic Atrophy (GA)2388
Total new diagnosis of GA patients by quarterly average in 2023
GroupValue95% CI
Patients With Geographic Atrophy (GA)3307
Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year Secondary · 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.

Mean number of visits in first quarter of 2019
GroupValue95% CI
Patients With Geographic Atrophy (GA)0.990± 0.97
Mean number of visits in first quarter of 2020
GroupValue95% CI
Patients With Geographic Atrophy (GA)0.983± 0.99
Mean number of visits in first quarter of 2021
GroupValue95% CI
Patients With Geographic Atrophy (GA)1.032± 1.01
Mean number of visits in first quarter of 2022
GroupValue95% CI
Patients With Geographic Atrophy (GA)1.057± 0.99
Mean number of visits in first quarter of 2023
GroupValue95% CI
Patients With Geographic Atrophy (GA)1.373± 0.90
Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter Secondary · 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.

Mean number of anti-VEGF injections in first quarter of 2019
GroupValue95% CI
Patients With Geographic Atrophy (GA)0.233± 0.63
Mean number of anti-VEGF injections in first quarter of 2020
GroupValue95% CI
Patients With Geographic Atrophy (GA)0.250± 0.65
Mean number of anti-VEGF injections in first quarter of 2021
GroupValue95% CI
Patients With Geographic Atrophy (GA)0.275± 0.68
Mean number of anti-VEGF injections in first quarter of 2022
GroupValue95% CI
Patients With Geographic Atrophy (GA)0.295± 0.70
Mean number of anti-VEGF injections in first quarter of 2023
GroupValue95% CI
Patients With Geographic Atrophy (GA)0.442± 0.82
Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up Secondary · 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.

Participants with ocular comorbidities in study eye: on or before index
GroupValue95% CI
Patients With Geographic Atrophy (GA)36518
Participants with ocular comorbidities in study eye: in the first year
GroupValue95% CI
Patients With Geographic Atrophy (GA)38507
Participants with ocular comorbidities in study eye: in the first 2 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)39506
Participants with ocular comorbidities in study eye: in the first 3 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)40077
Participants with ocular comorbidities in study eye: in the first 4 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)40382
Participants with ocular comorbidities in study eye: in the first 5 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)40546
HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant Secondary · 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.

Participants with corneal transplant in study eye: on or before index
GroupValue95% CI
Patients With Geographic Atrophy (GA)6
Participants with corneal transplant in study eye: in the first year
GroupValue95% CI
Patients With Geographic Atrophy (GA)7
Participants with corneal transplant in study eye: in the first 2 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)8
Participants with corneal transplant in study eye: In the first 3 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)10
Participants with corneal transplant in study eye: in the first 4 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)11
Participants with corneal transplant in study eye: in the first 5 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)11
HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery Secondary · 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.

Participants with incisional glaucoma surgery in study eye: on or before index
GroupValue95% CI
Patients With Geographic Atrophy (GA)0
Participants with incisional glaucoma surgery in study eye: in the first year
GroupValue95% CI
Patients With Geographic Atrophy (GA)0
Participants with incisional glaucoma surgery in study eye: in the first 2 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)0
Participants with incisional glaucoma surgery in study eye: in the first 3 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)0
Participants with incisional glaucoma surgery in study eye: in the first 4 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)0
Participants with incisional glaucoma surgery in study eye: in the first 5 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)0
HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy Secondary · 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.

Participants with vitrectomy performed on study eye: on or before index
GroupValue95% CI
Patients With Geographic Atrophy (GA)1579
Participants with vitrectomy performed on study eye: in the first year
GroupValue95% CI
Patients With Geographic Atrophy (GA)1858
Participants with vitrectomy performed on study eye: in the first 2 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)1955
Participants with vitrectomy performed on study eye: in the first 3 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)1995
Participants with vitrectomy performed on study eye: in the first 4 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)2038
Participants with vitrectomy performed on study eye: in the first 5 years
GroupValue95% CI
Patients With Geographic Atrophy (GA)2062

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Geographic Atrophy

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05891275.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing