Actively Recruiting

Age: 55Years - 99Years
All Genders
NCT06351657

Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

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

200

Participants Needed

7

Research Sites

115 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 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.

CONDITIONS

Official Title

Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic 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
  • Complete retinal pigment epithelium (RPE) and outer retinal atrophy (cRORA) with specific retinal features
  • Both eyes can be included if eligible
  • Clear optical media and good pupil dilation for imaging and testing
Not Eligible

You will not qualify if you...

  • Eye surgery within 3 months before baseline in the study eye
  • Previous anti-VEGF treatment in the study eye before baseline
  • History of pseudophakic cystoid macular edema in the study eye
  • Uncontrolled glaucoma in the study eye (IOP ≥ 25 mmHg despite treatment) or cup-to-disc ratio over 0.9
  • Other eye conditions requiring medical or surgical intervention during the study
  • Eye conditions that could affect treatment efficacy or require surgery (except cataract surgery and YAG capsulotomy)
  • Corneal problems affecting vision
  • Refractive error larger than 6 diopters or history of such error in pseudophakia or after refractive surgery
  • Use of drugs known to cause retinal toxicity (e.g., hydroxychloroquine, 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

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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