Actively Recruiting

Age: 55Years - 99Years
All Genders
NCT06351670

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

Led by Medical University of Vienna · Updated on 2025-05-15

500

Participants Needed

7

Research Sites

122 weeks

Total Duration

On this page

Sponsors

M

Medical University of Vienna

Lead Sponsor

U

University Medical Centre Ljubljana

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 55Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 55 and 99 years old
  • Early or intermediate AMD in at least one eye with drusen larger than 63 b5m and/or definite hyper- or hypopigmentary abnormalities, with or without reticular pseudodrusen
  • Both eyes included if both are eligible
  • Clear optical media and pupils dilated enough for imaging and functional testing
Not Eligible

You will not qualify if you...

  • Eye surgery in the study eye within 3 months before baseline
  • Previous anti-VEGF treatment in the study eye before baseline
  • History of pseudophakic cystoid macular edema (Irvine Gass Syndrome) in the study eye
  • Uncontrolled glaucoma in the study eye (intraocular pressure 65 25 mmHg despite treatment) or cup-to-disc ratio greater than 0.9
  • Other serious eye conditions in the study eye that may require medical or surgical intervention during the study
  • Eye conditions in the study eye that could affect treatment efficacy, compliance, or need surgery during the study (except cataract surgery and YAG capsulotomy)
  • Corneal damage or scarring affecting vision
  • Refractive error over 6 diopters, or history of such if pseudophakic or post-refractive surgery
  • Use of drugs that cause retinal toxicity (e.g., hydroxychloroquine or tamoxifen)
  • Presence of active macular neovascularization at baseline

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Medical University of Vienna

Vienna, Austria, 1090

Not Yet Recruiting

2

CHU Dijon

Dijon, France

Actively Recruiting

3

University Medical Center Ljubljana

Ljubljana, Slovenia

Actively Recruiting

4

Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed

Barcelona, Spain

Actively Recruiting

5

Vista Klinik Binningen

Binningen, Switzerland

Actively Recruiting

6

University of Zürich

Zurich, Switzerland

Actively Recruiting

7

Queen's Unviversity Belfast

Belfast, United Kingdom

Actively Recruiting

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Research Team

G

Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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