N/A
N=68,563
Patients With Geographic Atrophy and Their Patient Journey in the United States (US)
Geographic Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT05891275 ↗Enrolled (actual)
68,563
Serious AEs
—
Results posted
May 2025
Primary outcome: Primary: Change in Visual Acuity (VA) in Participant's Study Eye — -2.8; -5.9; -8.6; -10.3 Letters read
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Acuity (VA) in Participant's Study Eye |
-2.8; -5.9; -8.6; -10.3; -11.9 | — |
| PRIMARY Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye |
1866; 2271; 2191; 1764; 1247 | — |
| PRIMARY Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye |
1102; 1319; 1207; 936; 635 | — |
| PRIMARY Change in Lesion Location for Participants With wAMD in Study Eye |
9; 26; 28; 31; 44 | — |
| PRIMARY Change in Lesion Location for Participants With GA in Fellow Eye |
27; 41; 59; 67; 89 | — |
| PRIMARY Occurrence of GA Over Study Period |
2208; 2227; 1881; 2273; 2388; 3307 | — |
| SECONDARY Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year |
0.990; 0.983; 1.032; 1.057; 1.373 | — |
| SECONDARY Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter |
0.233; 0.250; 0.275; 0.295; 0.442 | — |
| SECONDARY Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up |
36518; 38507; 39506; 40077; 40382; 40546 | — |
| SECONDARY HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant |
6; 7; 8; 10; 11; 11 | — |
| SECONDARY HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy |
1579; 1858; 1955; 1995; 2038; 2062 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05891275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.