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A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression

NCT05698316 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-05-08

No results posted yet for this study

Summary

This is a multicentre retrospective and prospective cohort study with the goal to develop a well-characterised multimodal image database of eyes with intermediate AMD with and without early atrophy. The main objectives are:

1. Develop a collaborative well-characterised database on intermediate AMD with or without early atrophy.
2. Grading of these images to explore imaging markers of progression.
3. Develop predictive models as a secondary analysis of our dataset.

This study will recruit around 1.000 eyes in 6 months. All consenting patients who have had at least 3 clinic visits with multimodal imaging done at least at 6 months interval between 2 visits and meet the inclusion and exclusion criteria will be included in the study for retrospective data collection. Those with one visit remaining to complete 2 years, images will be acquired prospectively. In addition to the images, routine demographic data (age and sex) and available visual acuity (VA) (BCVA if possible, VA with Pinhole or VA with patient's glasses) will be collected. Multimodal imaging includes mandated macular OCT with or without enhanced depth imaging and infrared imaging. Fundus autofluorescence (AF) and multicolor imaging are optional. All imaging must be done on Heidelberg Spectralis system.

Conditions

  • Age Related Macular Degeneration
  • Intermediate AMD
  • Atrophy
  • Prediction

Interventions

DIAGNOSTIC_TEST

Collection of both retrospective and prospective data collection in 3 visits.

3 clinic visits with multimodal imaging done at least at 6 months interval between 2 visits and meet the inclusion and exclusion criteria. Those with one visit remaining to complete 2 years, images will be acquired prospectively. In addition to the images, routine demographic data (age and sex) and available visual acuity (VA) (BCVA if possible, VA with Pinhole or VA with patient's glasses) will be collected. Multimodal imaging includes mandated macular OCT with or without enhanced depth imaging and infrared imaging. Fundus autofluorescence (AF) and multicolor imaging are optional. All imaging must be done on Heidelberg Spectralis system.

Sponsors & Collaborators

  • European Vision Institute Clinical Research Network

    collaborator NETWORK

  • Association for Innovation and Biomedical Research on Light and Image

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2024-02-22
Completion
2025-12-31

Countries

  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Portugal
  • 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 NCT05698316 on ClinicalTrials.gov