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:
* Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging. * Identify and quantify focal and global alterations in the retina in regard to disease progression. * Evaluate the monitoring of AMD progression using approved AI algorithms.
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:
* Scanning Laser Fundus Photography * Color Fundus Photography (CFP) * Optical Coherence Tomography (OCT) * Optical Coherence Tomography Angiography (OCTA)
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.
Age: 55-99 years old
Complete RPE and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 µm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.
If both eyes are eligible, both eyes will be included in the cohort study.
Clear optical media and adequate pupillary dilation for imaging and functional testin
Any surgical treatment of the eye within 3 months prior to baseline in the study eye
History of anti-VEGF treatment in the study eye before baseline
History of pseudophakic cystoid macular edema (Irvine Gass Syndrome) in the study eye
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio > 0.9
Patients will be recruited from each center's respective outpatient clinic and/or by referral from primary eye care (e.g. optometrist).
Case-only
Prospective
Not listed
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.
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.
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
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Medical University of Vienna
Lead sponsor
University Medical Centre Ljubljana
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator
University of Zurich
Collaborator
Vista Klinik
Collaborator
Queen's University, Belfast
Collaborator
Fundacion Clinic per a la Recerca Biomédica
Collaborator
