AMD Clinical Trial
Official title:
Understanding Imaging Biomarkers That Predict the Progression of Age-Related Macular Degeneration on Multi-modal Novel Retinal Technologies
To study qualitatively and quantitatively the Imaging Biomarkers (IBs) on Multi-modal Imaging with Novel technologies (MINT), in order to understand their role in prediction of the Age-related Macular Degeneration (AMD) progression in eyes with and without treatment. The understanding of IBs will allow early detection of AMD, prediction of its evolution, and guidance for the best options for stratified/individualized treatment of AMD.
The qualitative studies will explore use of OCT Angiography (OCTA), Swept Source OCT
(SS-OCT), Ultra-Wide Field Fluorescein Angiography (UWF-FA), Adaptive Optic Scanning Laser
Ophthalmoscopy (AO-SLO), Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO), Retro Mode
Imaging (RMI) and other novel technologies for the retinal diagnosis. Morphologic qualitative
IBs described in the literature like macular neovascularization pattern, retinal tubulations,
choriocapillary preservation, retinal pigment epithelium atrophy, drusen patterns, etc as
well as other IBPAMD original IBs classified in morphopathogenic categories like IBs
related-to-MNV, IBs related-to-atrophy, IBs related-to macular chorio-retinal architecture,
etc are analyzed in granular fashion by multi-modal imaging approach before and after
different treatments for AMD.
The quantitative IBs assessment will be done in dual mode - classic and original to the
IBPAMD trial. The lesions are quantitatively assessed on one hand, by using the classic
measurements of the greatest diameter, total lesions area, vessels density, fractal
dimension, etc, based on the classic concept of measurements expressed in absolute values
(mm, mm2 or pixels). The same lesions are quantitatively assessed by using the original
IBPAMD algorithm and software (SITE-app) that introduce a new concept in the quantification
of the retinal lesions, the assessment of differences reported to the baseline.
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