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

NCT06351657 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-05-15

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    collaborator OTHER

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • University of Zurich

    collaborator OTHER

  • Vista Klinik

    collaborator OTHER

  • Queen's University, Belfast

    collaborator OTHER

  • Fundacion Clinic per a la Recerca Biomédica

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Eligibility

Min Age
55 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Austria
  • France
  • Slovenia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06351657 on ClinicalTrials.gov