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

NCT06351670 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

  • Age-Related Macular Degeneration

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    collaborator OTHER

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • Queen's University, Belfast

    collaborator OTHER

  • University of Zurich

    collaborator OTHER

  • Vista Klinik

    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
2025-02-25
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

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

Study Locations

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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 NCT06351670 on ClinicalTrials.gov