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| Name | Class |
|---|---|
| University Medical Centre Ljubljana | OTHER |
| Centre Hospitalier Universitaire Dijon | OTHER |
| Queen's University, Belfast | OTHER |
| University of Zurich |
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The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are:
All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:
No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label.
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| Measure | Description | Time Frame |
|---|---|---|
| To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for conversion to advanced AMD. | The correlation between biomarkers (independent variables) and progression will be assessed by linear mixed models or prospectively by Cox-regression models. Artificial intelligence models will be applied to assess progression speed and predict local and global progression. Mixed Effects models will be calculated to estimate the association between independent variables, including the timepoint as an independent variable, on individual markers of progression (PR thinning and PR loss expansion). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To identify and quantify disease progression-related biomarkers | Longitudinal assessments of imaging biomarkers are performed in a descriptive manner. The following biomarkers will be evaluated in detail as independent variables:
The correlation between biomarkers (independent variables) and disease progression will be assessed by linear mixed models or prospectively by Cox-regression models. Mixed Effects models will be calculated to estimate the association between independent variables, including the timepoint as an independent variable, on individual markers of progression (PR thinning and PR loss expansion). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from each center's respective outpatient clinic and/or by referral from primary eye care (e.g. optometrist).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc | Contact | +43 1 40400-73419 | gregor.reiter@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Not yet recruiting | Vienna | 1090 | Austria |
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| OTHER |
| Vista Klinik | OTHER |
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
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| 2 years |
| To evaluate monitoring of AMD progression assisted by AI algorithms | The following will be provided by AI-based image analysis of the GA Monitor (independent variables used to detect an event for the Cox-regression model):
The following will be provided by AI-based image analysis of the Fluid Monitor (independent variables used to detect an event for the Cox-regression model):
| 2 years |
| CHU Dijon | Recruiting | Dijon | France |
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| University Medical Center Ljubljana | Recruiting | Ljubljana | Slovenia |
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| Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed | Recruiting | Barcelona | Spain |
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| Vista Klinik Binningen | Recruiting | Binningen | Switzerland |
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| University of Zürich | Recruiting | Zurich | Switzerland |
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| Queen's Unviversity Belfast | Recruiting | Belfast | United Kingdom |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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