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

NCT05698316 | Active Not Recruiting DMC

• 1 other identifier: ECR-AMD-2023-14
• Study Type: observational
• Target: 1,000
• Locations: 9 countries
• Sites: 25

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

Conditions

Age Related Macular Degeneration; Intermediate AMD; Atrophy; Prediction

Outcome Measures

Primary Outcomes (1)

• Incidence of conversion to atrophy at two years

  Number of patients who developed new or increasing atrophy

  24 months

Study Arms (1)

Age related macular degeneration

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

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

Interventions

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

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.

Age related macular degeneration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with Age-related macular degeneration (AMD)

You may qualify if:

• Each dataset per patient should have one eye as the study eye with:
• Intermediate AMD with no atrophy and no subretinal drusenoid deposits
• Intermediate AMD with no atrophy with subretinal drusenoid deposits
• Intermediate AMD with early atrophy (iRORA) with no Subretinal drusenoid deposits
• Intermediate AMD with early atrophy (iRORA) with Subretinal drusenoid deposits
• Intermediate AMD with evidence of cRORA
• Non-study eye images will not be exported but information about the status of the macula should be added using the following options:
• Established Geographic Atrophy (cRORA)
• Exudative AMD (presence of MNV)
• Early AMD
• Healthy macula

You may not qualify if:

• Both eyes have exudative AMD or geographic atrophy at baseline.
• Co-existent ocular disease: Any other ocular condition that, in the investigator's opinion, might affect or alter visual acuity during the study.
• Any patient who has opted out of their information being used for research nationally or locally at any Member Site.

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead
• European Vision Institute Clinical Research Network: collaborator

Study Sites (25)

Department of Ophthalmology, University Hospital, Nantes

Nantes, France

Location

Department of Ophthalmology University of Bonn

Bonn, Germany

Location

Department of Ophthalmology University of Freiburg

Freiburg im Breisgau, Germany

Location

Department of Ophthalmology Justus/Liebig/University/Giessen

Giesen, Germany

Location

Department of Ophthalmology St. Franziskus/Hospital Münster

Münster, Germany

Location

Department of Ophthalmology University of Muenster Medical Center

Münster, Germany

Location

Eye Clinic Sulzbach, Knappschaft Hospital Saar

Sulzbach, Germany

Location

Royal Victoria Eye and Ear Research Foundation

Dublin, Ireland

Location

Medical Retina Service, Operative Unit Ophthalmology / MultiMedica Spa (IRCCSMM)

Milan, Italy

Location

Eye Unit, University Hospital Maggiore della Carità

Novara, Italy

Location

Department of Ophthalmology University of Udine

Udine, Italy

Location

Department of Ophthalmology Radboud University Medical Centre Nijmegen

Nijmegen, Netherlands

Location

AIBILI-CEC (AIBILI- Clinical Trials Centre)

Coimbra, Portugal

Location

Espaço Médico de Coimbra

Coimbra, Portugal

Location

Instituto de Oftalmologia Dr. Gama Pinto

Lisbon, Portugal

Location

Department of Ophthalmology Porto Medical School / Hospital S. João

Porto, Portugal

Location

Institut Català de Retina (ICR), Clinical Trial Unit

Barcelona, Spain

Location

Institut de la Màcula Centro Médico Teknon

Barcelona, Spain

Location

Valles Ophthalmology Research, S.L.

Barcelona, Spain

Location

Clínica Oftalmológica AIKEN / Fundación Aiken de la Comunitat Valenciana

Valencia, Spain

Location

University Hospital Basel, University Eye Clinic, Basel

Basel, Switzerland

Location

Swiss Visio Retina Research Center, Swiss Visio Montchoisi

Lausanne, Switzerland

Location

Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust

Cheltenham, United Kingdom

Location

Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust

London, United Kingdom

Location

Related Publications (4)

• Ferris FL 3rd, Wilkinson CP, Bird A, Chakravarthy U, Chew E, Csaky K, Sadda SR; Beckman Initiative for Macular Research Classification Committee. Clinical classification of age-related macular degeneration. Ophthalmology. 2013 Apr;120(4):844-51. doi: 10.1016/j.ophtha.2012.10.036. Epub 2013 Jan 16.

  PMID: 23332590 BACKGROUND

• Spaide RF, Ooto S, Curcio CA. Subretinal drusenoid deposits AKA pseudodrusen. Surv Ophthalmol. 2018 Nov-Dec;63(6):782-815. doi: 10.1016/j.survophthal.2018.05.005. Epub 2018 May 31.

  PMID: 29859199 BACKGROUND

• Kim DY, Loo J, Farsiu S, Jaffe GJ. COMPARISON OF SINGLE DRUSEN SIZE ON COLOR FUNDUS PHOTOGRAPHY AND SPECTRAL-DOMAIN OPTICAL COHERENCE TOMOGRAPHY. Retina. 2021 Aug 1;41(8):1715-1722. doi: 10.1097/IAE.0000000000003099.

  PMID: 33411474 BACKGROUND

• Sadda SR, Guymer R, Holz FG, Schmitz-Valckenberg S, Curcio CA, Bird AC, Blodi BA, Bottoni F, Chakravarthy U, Chew EY, Csaky K, Danis RP, Fleckenstein M, Freund KB, Grunwald J, Hoyng CB, Jaffe GJ, Liakopoulos S, Mones JM, Pauleikhoff D, Rosenfeld PJ, Sarraf D, Spaide RF, Tadayoni R, Tufail A, Wolf S, Staurenghi G. Consensus Definition for Atrophy Associated with Age-Related Macular Degeneration on OCT: Classification of Atrophy Report 3. Ophthalmology. 2018 Apr;125(4):537-548. doi: 10.1016/j.ophtha.2017.09.028. Epub 2017 Nov 2.

  PMID: 29103793 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Atrophy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 26, 2023
• Study Start: May 4, 2023
• Primary Completion: February 22, 2024
• Study Completion: December 31, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

GB (3); CH (2); PT (4); ES (4); IE (1); DE (6); NL (1); IT (3); FR (1)