Trial Outcomes & Findings for Patients With Geographic Atrophy and Their Patient Journey in the United States (US) (NCT NCT05891275)
NCT ID: NCT05891275
Last Updated: 2025-05-01
Results Overview
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.
COMPLETED
68563 participants
From index date of GA diagnosis up to 5 years
2025-05-01
Participant Flow
This was an observational cohort study based on existing data aimed to quantify and describe patients with a diagnosis of geographic atrophy (GA) in at least one eye, the progression to wet or neovascular age-related macular degeneration (wAMD) in both eyes, and the progression to GA in the fellow eye.
Only subjects that met all inclusion and none of the exclusion criteria were included. Subjects from the Vestrum database aged 50+ with information on laterality, and a GA diagnosis between January 1, 2015, to April 30, 2023, were analyzed. While both eyes participated in the study, one eye per participant was analyzed for outcome measures.
Participant milestones
| Measure |
Patients With Geographic Atrophy (GA)
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.
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|---|---|
|
Overall Study
STARTED
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68563
|
|
Overall Study
COMPLETED
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68563
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With Geographic Atrophy (GA)
n=68563 Participants
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.
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|---|---|
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Age, Continuous
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82 Years
STANDARD_DEVIATION 9 • n=68563 Participants
|
|
Sex/Gender, Customized
Female
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44046 Participants
n=68563 Participants
|
|
Sex/Gender, Customized
Male
|
23632 Participants
n=68563 Participants
|
|
Sex/Gender, Customized
Not specified
|
885 Participants
n=68563 Participants
|
|
GA laterality
Participants with unilateral GA
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36221 Participants
n=68563 Participants
|
|
GA laterality
Participants with bilateral GA
|
32342 Participants
n=68563 Participants
|
|
Wet (neovascular) age-related macular degeneration (wAMD)
Study eye with wAMD
|
12937 Participants
n=68563 Participants
|
|
Wet (neovascular) age-related macular degeneration (wAMD)
Study eye without wAMD
|
55626 Participants
n=68563 Participants
|
|
Wet (neovascular) age-related macular degeneration (wAMD)
Fellow eye with wAMD
|
28728 Participants
n=68563 Participants
|
|
Wet (neovascular) age-related macular degeneration (wAMD)
Fellow eye without wAMD
|
39835 Participants
n=68563 Participants
|
|
Lesion location at index
Subfoveal
|
39163 Participants
n=68563 Participants
|
|
Lesion location at index
Extrafoveal
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29400 Participants
n=68563 Participants
|
PRIMARY outcome
Timeframe: From index date of GA diagnosis up to 5 yearsPopulation: Participants with GA at the index date and at least one year of follow-up data, with a VA reading at index, and at least one more VA reading at a subsequent follow-up year. The populations were different for each year since patients should have certain follow-up information to contribute to each cohort, and some participants had data in more than one year. Only those participants with VA readings at appropriate timepoints, with appropriate follow up, were analyzed.
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.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=25477 Participants
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.
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|---|---|
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Change in Visual Acuity (VA) in Participant's Study Eye
Change in VA (Year 1)
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-2.8 Letters read
Interval -3.0 to -2.6
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|
Change in Visual Acuity (VA) in Participant's Study Eye
Change in VA (Year 2)
|
-5.9 Letters read
Interval -6.2 to -5.6
|
|
Change in Visual Acuity (VA) in Participant's Study Eye
Change in VA (Year 3)
|
-8.6 Letters read
Interval -9.0 to -8.2
|
|
Change in Visual Acuity (VA) in Participant's Study Eye
Change in VA (Year 4)
|
-10.3 Letters read
Interval -10.9 to -9.8
|
|
Change in Visual Acuity (VA) in Participant's Study Eye
Change in VA (Year 5)
|
-11.9 Letters read
Interval -12.6 to -11.2
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PRIMARY outcome
Timeframe: From index date of GA diagnosis up to 5 years.Population: Participants with GA at the index date and at least one year of follow-up data, excluding patients with wAMD prior to index. Only participants with appropriate follow up were analyzed. The populations were different for each year since patients should have certain follow-up information to contribute to each cohort, and some participants had data in more than one year.
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.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=27974 Participants
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.
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|---|---|
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Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye
Participants with wAMD in 1+ years
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1866 Participants
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|
Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye
Participants with wAMD in 2+ years
|
2271 Participants
|
|
Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye
Participants with wAMD in 3+ years
|
2191 Participants
|
|
Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye
Participants with wAMD in 4+ years
|
1764 Participants
|
|
Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye
Participants with wAMD in 5+ years
|
1247 Participants
|
PRIMARY outcome
Timeframe: From index date of GA diagnosis up to 5 years.Population: Participants with GA at the index date and at least one year of follow-up data, excluding bilateral patients at index. Only participants with appropriate follow up were analyzed. The populations were different for each year since patients should have certain follow-up information to contribute to each cohort, and some participants had data in more than one year.
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.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=19946 Participants
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.
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|---|---|
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Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye
Participants with GA in fellow eye in 5+ years
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635 Participants
|
|
Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye
Participants with GA in fellow eye in 1+ years
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1102 Participants
|
|
Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye
Participants with GA in fellow eye in 2+ years
|
1319 Participants
|
|
Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye
Participants with GA in fellow eye in 3+ years
|
1207 Participants
|
|
Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye
Participants with GA in fellow eye in 4+ years
|
936 Participants
|
PRIMARY outcome
Timeframe: From index date of GA diagnosis up to 5 yearsPopulation: Participants with GA at index date and five years of follow-up data who developed wAMD in the study eye after the index date. The populations were different for each year since only patients with lesion location information contributed to each cohort. Only participants with appropriate follow up were analyzed.
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.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=3449 Participants
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.
|
|---|---|
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Change in Lesion Location for Participants With wAMD in Study Eye
Participants with change of lesion location in Year 1
|
9 Participants
|
|
Change in Lesion Location for Participants With wAMD in Study Eye
Participants with change of lesion location in Year 2
|
26 Participants
|
|
Change in Lesion Location for Participants With wAMD in Study Eye
Participants with change of lesion location in Year 3
|
28 Participants
|
|
Change in Lesion Location for Participants With wAMD in Study Eye
Participants with change of lesion location in Year 4
|
31 Participants
|
|
Change in Lesion Location for Participants With wAMD in Study Eye
Participants with change of lesion location in Year 5
|
44 Participants
|
PRIMARY outcome
Timeframe: From index date of GA diagnosis up to 5 yearsPopulation: Participants with GA at the index date and five years of follow-up data who developed GA in the fellow eye after the index date. The populations were different for each year since only patients with lesion location information contributed to each cohort. Only participants with appropriate follow up were analyzed.
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.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=2671 Participants
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.
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|---|---|
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Change in Lesion Location for Participants With GA in Fellow Eye
Participants with change of lesion location in Year 1
|
27 Participants
|
|
Change in Lesion Location for Participants With GA in Fellow Eye
Participants with change of lesion location in Year 2
|
41 Participants
|
|
Change in Lesion Location for Participants With GA in Fellow Eye
Participants with change of lesion location in Year 3
|
59 Participants
|
|
Change in Lesion Location for Participants With GA in Fellow Eye
Participants with change of lesion location in Year 4
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67 Participants
|
|
Change in Lesion Location for Participants With GA in Fellow Eye
Participants with change of lesion location in Year 5
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89 Participants
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PRIMARY outcome
Timeframe: Number of yearly counts of GA from 2018 to 2013, by quarterly average.Population: Participants newly diagnosed with GA by quarterly average per year, for 2018-2023. Given the nature of the database, it was not possible to assess the prevalence or incidence of GA, but the absolute numbers of first time GA diagnosis, which is presented here.
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.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=48832 Participants
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.
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|---|---|
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Occurrence of GA Over Study Period
Total new diagnosis of GA patients by quarterly average in 2019
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2227 Number of participants
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|
Occurrence of GA Over Study Period
Total new diagnosis of GA patients by quarterly average in 2020
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1881 Number of participants
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|
Occurrence of GA Over Study Period
Total new diagnosis of GA patients by quarterly average in 2021
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2273 Number of participants
|
|
Occurrence of GA Over Study Period
Total new diagnosis of GA patients by quarterly average in 2018
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2208 Number of participants
|
|
Occurrence of GA Over Study Period
Total new diagnosis of GA patients by quarterly average in 2022
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2388 Number of participants
|
|
Occurrence of GA Over Study Period
Total new diagnosis of GA patients by quarterly average in 2023
|
3307 Number of participants
|
SECONDARY outcome
Timeframe: Mean number of quarterly visits from 2019 up to 2023.Population: Participants were evaluated from the incident date of GA and assessed on a yearly basis for changes in physician habits over time. A patient visit or encounter was identified in the database any time a patient visited one of the panel physicians, without filtering on follow-up information. Results are presented only for first quarters of 2019 to 2023 respectively.
The retinal disease-related healthcare resource utilization (HCRU) outcome, number of visits by participants per quarter in a year is reported.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=68563 Participants
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.
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|---|---|
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Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year
Mean number of visits in first quarter of 2019
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0.990 Mean number of visits per quarter
Standard Deviation 0.97
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Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year
Mean number of visits in first quarter of 2020
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0.983 Mean number of visits per quarter
Standard Deviation 0.99
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|
Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year
Mean number of visits in first quarter of 2021
|
1.032 Mean number of visits per quarter
Standard Deviation 1.01
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|
Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year
Mean number of visits in first quarter of 2022
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1.057 Mean number of visits per quarter
Standard Deviation 0.99
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Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year
Mean number of visits in first quarter of 2023
|
1.373 Mean number of visits per quarter
Standard Deviation 0.90
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SECONDARY outcome
Timeframe: Mean number of quarterly anti-VEGF injections from 2019 up to 2023.Population: Participants were evaluated from index diagnosis and last encounter date, including patients in quarters with no anti-VEGF treatments, without filtering on follow-up information. Results are presented only for first quarters of 2019 to 2023 respectively.
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.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=68563 Participants
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.
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|---|---|
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Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter
Mean number of anti-VEGF injections in first quarter of 2019
|
0.233 Mean number of anti-VEGF injections
Standard Deviation 0.63
|
|
Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter
Mean number of anti-VEGF injections in first quarter of 2020
|
0.250 Mean number of anti-VEGF injections
Standard Deviation 0.65
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Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter
Mean number of anti-VEGF injections in first quarter of 2021
|
0.275 Mean number of anti-VEGF injections
Standard Deviation 0.68
|
|
Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter
Mean number of anti-VEGF injections in first quarter of 2022
|
0.295 Mean number of anti-VEGF injections
Standard Deviation 0.70
|
|
Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter
Mean number of anti-VEGF injections in first quarter of 2023
|
0.442 Mean number of anti-VEGF injections
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Total number of participants with ocular comorbidities were documented from index date up to 5 years.Population: Participants with GA were tracked longitudinally (yearly) from index date of GA diagnosis in the database for occurrence of ocular comorbidities.
The retinal disease-related HCRU outcome, number of ocular comorbidities by year of follow up is reported.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=68563 Participants
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.
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|---|---|
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Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up
Participants with ocular comorbidities in study eye: on or before index
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36518 Participants
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Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up
Participants with ocular comorbidities in study eye: in the first year
|
38507 Participants
|
|
Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up
Participants with ocular comorbidities in study eye: in the first 2 years
|
39506 Participants
|
|
Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up
Participants with ocular comorbidities in study eye: in the first 3 years
|
40077 Participants
|
|
Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up
Participants with ocular comorbidities in study eye: in the first 4 years
|
40382 Participants
|
|
Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up
Participants with ocular comorbidities in study eye: in the first 5 years
|
40546 Participants
|
SECONDARY outcome
Timeframe: Total number of participants with corneal transplants were documented from index date up to 5 years.Population: Participants with GA were tracked longitudinally (yearly) from index date of GA diagnosis in the database for occurrence of corneal transplantation.
The number of participants with corneal transplant during the observational period is reported.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=68563 Participants
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.
|
|---|---|
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HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant
Participants with corneal transplant in study eye: on or before index
|
6 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant
Participants with corneal transplant in study eye: in the first year
|
7 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant
Participants with corneal transplant in study eye: in the first 2 years
|
8 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant
Participants with corneal transplant in study eye: In the first 3 years
|
10 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant
Participants with corneal transplant in study eye: in the first 4 years
|
11 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant
Participants with corneal transplant in study eye: in the first 5 years
|
11 Participants
|
SECONDARY outcome
Timeframe: Total number of participants with incisional glaucoma surgery were documented from index date up to 5 years.Population: Participants with GA were tracked longitudinally (yearly) from index date of GA diagnosis in the database for occurrence of incisional glaucoma surgery.
Number of participants with incisional glaucoma surgery during the observational period is reported.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=68563 Participants
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.
|
|---|---|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery
Participants with incisional glaucoma surgery in study eye: on or before index
|
0 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery
Participants with incisional glaucoma surgery in study eye: in the first year
|
0 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery
Participants with incisional glaucoma surgery in study eye: in the first 2 years
|
0 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery
Participants with incisional glaucoma surgery in study eye: in the first 3 years
|
0 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery
Participants with incisional glaucoma surgery in study eye: in the first 4 years
|
0 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery
Participants with incisional glaucoma surgery in study eye: in the first 5 years
|
0 Participants
|
SECONDARY outcome
Timeframe: Total number of participants with vitrectomy were documented from index date up to 5 years.Population: Participants with GA were tracked longitudinally (yearly) from index date of GA diagnosis in the database for occurrence of vitrectomy.
Number of participants with vitrectomy during the observational period is reported.
Outcome measures
| Measure |
Patients With Geographic Atrophy (GA)
n=68563 Participants
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.
|
|---|---|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy
Participants with vitrectomy performed on study eye: in the first 3 years
|
1995 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy
Participants with vitrectomy performed on study eye: on or before index
|
1579 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy
Participants with vitrectomy performed on study eye: in the first year
|
1858 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy
Participants with vitrectomy performed on study eye: in the first 2 years
|
1955 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy
Participants with vitrectomy performed on study eye: in the first 4 years
|
2038 Participants
|
|
HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy
Participants with vitrectomy performed on study eye: in the first 5 years
|
2062 Participants
|
Adverse Events
Patients With Geographic Atrophy (GA)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER