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Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

Recruitingn/aAges 55 Years - 99 YearsAllMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Any concurrent intraocular condition in the study eye (e.g. advanced cataract or moderate/severe diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition * Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could cause an unwanted effect on treatment efficacy, compliance or require intraocular surgery (except for cataract surgery and YAG capsulotomy) during the study period * Presence of corneal decompensation, haze or scarring with an impact on BCVA * Refractive error larger than 6 diopters. In case of pseudophakia or refractive surgery: History of refractive error larger than 6 diopters. * Intake of drugs known to cause retinal toxicity (e.g. hydroxychloroquine or tamoxifen) * Presence of active macular neovascularization at baseline
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What it tests

  • Not listed
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Where

7 sites
Medical University of Vienna
Vienna, Austria
CHU Dijon
Dijon, France
University Medical Center Ljubljana
Ljubljana, Slovenia
Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed
Barcelona, Spain
Vista Klinik Binningen
Binningen, Switzerland
University of Zürich
Zurich, Switzerland
Queen's Unviversity Belfast
Belfast, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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