An observational study in Age-Related Macular Degeneration and Geographic Atrophy, sponsored by Medical University of Vienna. Recruiting at 7 sites in 6 countries. Open to participants aged 55 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Medical University of Vienna · Observational
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 200 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from each center's respective outpatient clinic and/or by referral from primary eye care (e.g. optometrist).
Exclusion Criteria:
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.
Time frame: 2 years
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: * Hyperreflective Foci (HRF) (scale, nL) * Drusen volume/Refractile drusen (scale, nL) * Subretinal Drusenoid Deposits (SDD) (scale, mm2) * PR loss/RPE loss ratio (scale, ratio) * GA lesion size (mm2) * Foveal involvement (categorical; yes or no) * Thinning of outer retinal layers (PR thinning) (scale, µm) * Other retinal biomarkers if relevant to the progression of GA The association between biomarkers and GA progression will be assessed by linear mixed models.
Time frame: 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): * RPE integrity loss (mm2) in the 1mm central area, 6mm area, and the respective relative change to previous visit * PR integrity loss (mm2) in the 1mm central area, 6mm area, and the respective relative change to previous visit
Time frame: 2 years
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Medical University of Vienna