Geographic AtrophyNCT05891275

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

An observational study of Geographic Atrophy, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Geographic Atrophy
How many people: 68,563 participants
Where: 1 siteUnited States
Study dates: 31 May 2023to 1 Dec 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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).

Who cannot join

Patients without the information of laterality will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

CorEvitas HQ
Waltham, Massachusetts, 02451

Other trials in United States

About this study

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

Conditions: Geographic Atrophy
Medical subject headings: Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05891275
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The retinal disease-related healthcare resource utilization (HCRU) outcome, number of visits by participants per quarter in a year is reported.
Measured: Mean number of quarterly visits from 2019 up to 2023.
Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter
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.
Measured: 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
The retinal disease-related HCRU outcome, number of ocular comorbidities by year of follow up is reported.
Measured: 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
The number of participants with corneal transplant during the observational period is reported.
Measured: 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
Number of participants with incisional glaucoma surgery during the observational period is reported.
Measured: Total number of participants with incisional glaucoma surgery were documented from index date up to 5 years.
HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy
Number of participants with vitrectomy during the observational period is reported.
Measured: Total number of participants with vitrectomy were documented from index date up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 20231 Dec 2023

First posted6 Jun 2023
Study start31 May 2023
Primary completion1 Dec 2023
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Geographic AtrophyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 68,563 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05891275
Sponsor's protocol ID: 1484-0014
Status last verified: Apr 2025
First submitted: 26 May 2023
Last updated: 1 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration

All Geographic Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of Patients With Geographic Atrophy (GA) in the US
ClinicalTrials.gov ID: NCT05891275
Acronym / sponsor ID: 1484-0014
Conditions: Geographic Atrophy
Study type: Observational
Recruitment status: Completed
Enrolment: 68,563 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 31 May 2023 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 6 Jun 2023 (actual)
Results: Posted 1 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: US patients ≥50 years, with a Geographic Atrophy diagnosis in at least one eye

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (1 listed)

Patients without the information of laterality will be excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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.
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.
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.
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.

6 secondary outcomes

Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year
Time frame: Mean number of quarterly visits from 2019 up to 2023.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 1 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Geographic Atrophy (GA)	68,563	68,563

Primary outcome: Change in Visual Acuity (VA) in Participant's Study Eye

Time frame: From index date of GA diagnosis up to 5 years. Mean (95% Confidence Interval). Unit: Letters read

Measure	Patients With Geographic Atrophy (GA) n = 25477
Change in VA (Year 1)	-2.8 (-3.0 to -2.6)
Change in VA (Year 2)	-5.9 (-6.2 to -5.6)
Change in VA (Year 3)	-8.6 (-9.0 to -8.2)
Change in VA (Year 4)	-10.3 (-10.9 to -9.8)
Change in VA (Year 5)	-11.9 (-12.6 to -11.2)

Population analysed: 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.

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Patients With Geographic Atrophy (GA) n = 27974
Participants with wAMD in 1+ years	1866
Participants with wAMD in 2+ years	2271
Participants with wAMD in 3+ years	2191
Participants with wAMD in 4+ years	1764
Participants with wAMD in 5+ years	1247

Population analysed: 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.

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Patients With Geographic Atrophy (GA) n = 19946
Participants with GA in fellow eye in 1+ years	1102
Participants with GA in fellow eye in 2+ years	1319
Participants with GA in fellow eye in 3+ years	1207
Participants with GA in fellow eye in 4+ years	936
Participants with GA in fellow eye in 5+ years	635

Population analysed: 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.

Primary outcome: Change in Lesion Location for Participants With wAMD in Study Eye

Time frame: From index date of GA diagnosis up to 5 years. Count of participants. Unit: Participants

Measure	Patients With Geographic Atrophy (GA) n = 3449
Participants with change of lesion location in Year 1	9
Participants with change of lesion location in Year 2	26
Participants with change of lesion location in Year 3	28
Participants with change of lesion location in Year 4	31
Participants with change of lesion location in Year 5	44

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was not applicable for this study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Geographic Atrophy (GA)	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Related trials for Geographic Atrophy

Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Geographic Atrophy, run by Boehringer Ingelheim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Acuity (VA) in Participant's Study Eye (time frame: From index date of GA diagnosis up to 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05891275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.