Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression in a Prospective, Multinational, Multicentre Observational Study

Status: Recruiting
Location: See all (7) locations...
Study Type: Observational
SUMMARY

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: * Identify and quantify focal and global alterations in the retina in regard to disease progression. * Assess the individual risk of disease progression in intermediate AMD patients converting to advanced AMD based on imaging. * Specify the course of disease in regard to the sequence of events that lead to the conversion to advanced AMD * Enhance the ability to classify AMD using artificial intelligence in addition to traditional models. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 99
Healthy Volunteers: f
View:

• Age: 55-99 years old

• Early or intermediate AMD in at least one eye (drusen \> 63 µm and/or any definite hyper- or hypopigmentary abnormalities with or without reticular pseudodrusen)

• 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 testing.

Locations
Other Locations
Austria
Medical University of Vienna
NOT_YET_RECRUITING
Vienna
France
CHU Dijon
RECRUITING
Dijon
Slovenia
University Medical Center Ljubljana
RECRUITING
Ljubljana
Spain
Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed
RECRUITING
Barcelona
Switzerland
Vista Klinik Binningen
RECRUITING
Binningen
University of Zürich
RECRUITING
Zurich
United Kingdom
Queen's Unviversity Belfast
RECRUITING
Belfast
Contact Information
Primary
Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc
gregor.reiter@meduniwien.ac.at
+43 1 40400-73419
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2027-07
Participants
Target number of participants: 500
Sponsors
Collaborators: University Medical Centre Ljubljana, Fundacion Clinic per a la Recerca Biomédica, Centre Hospitalier Universitaire Dijon, Vista Klinik, Queen's University, Belfast, University of Zurich
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov