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| Name | Class |
|---|---|
| University Medical Centre Ljubljana | OTHER |
| Centre Hospitalier Universitaire Dijon | OTHER |
| University of Zurich | OTHER |
| Vista Klinik |
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The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two 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:
Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.
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 fast geographic atrophy (GA) progression | The association between biomarkers and GA progression will be assessed by linear mixed 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 the above mentioned independent variables, including the timepoint as an independent variable, on individual markers of progression (RPE and PR thinning). The r-squared value of the predicted increase in atrophy area will be used as an endpoint assessment to evaluate the predictive model. | 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 association between biomarkers and GA progression will be assessed by linear mixed models. |
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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 | Austria |
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| OTHER |
| Queen's University, Belfast | OTHER |
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
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| 2 years |
| To evaluate monitoring AMD progression using approved AI algorithms. | The following will be provided by AI-based image analysis of the GA Monitor (independent variables):
| 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 |
|
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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