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ACTIVE NOT RECRUITING
NCT05698316

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

Sponsor: Association for Innovation and Biomedical Research on Light and Image

View on ClinicalTrials.gov

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.

Official title: A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression: (INTERCEPT-AMD)

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2023-05-04

Completion Date

2025-12-31

Last Updated

2025-09-30

Healthy Volunteers

No

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.

Locations (25)

Department of Ophthalmology, University Hospital, Nantes

Nantes, France

Department of Ophthalmology University of Bonn

Bonn, Germany

Department of Ophthalmology University of Freiburg

Freiburg im Breisgau, Germany

Department of Ophthalmology Justus/Liebig/University/Giessen

Giesen, Germany

Department of Ophthalmology St. Franziskus/Hospital Münster

Münster, Germany

Department of Ophthalmology University of Muenster Medical Center

Münster, Germany

Eye Clinic Sulzbach, Knappschaft Hospital Saar

Sulzbach, Germany

Royal Victoria Eye and Ear Research Foundation

Dublin, Ireland

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

Milan, Italy

Eye Unit, University Hospital Maggiore della Carità

Novara, Italy

Department of Ophthalmology University of Udine

Udine, Italy

Department of Ophthalmology Radboud University Medical Centre Nijmegen

Nijmegen, Netherlands

AIBILI-CEC (AIBILI- Clinical Trials Centre)

Coimbra, Portugal

Espaço Médico de Coimbra

Coimbra, Portugal

Instituto de Oftalmologia Dr. Gama Pinto

Lisbon, Portugal

Department of Ophthalmology Porto Medical School / Hospital S. João

Porto, Portugal

Institut Català de Retina (ICR), Clinical Trial Unit

Barcelona, Spain

Institut de la Màcula Centro Médico Teknon

Barcelona, Spain

Valles Ophthalmology Research, S.L.

Barcelona, Spain

Clínica Oftalmológica AIKEN / Fundación Aiken de la Comunitat Valenciana

Valencia, Spain

University Hospital Basel, University Eye Clinic, Basel

Basel, Switzerland

Swiss Visio Retina Research Center, Swiss Visio Montchoisi

Lausanne, Switzerland

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

Cheltenham, United Kingdom

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

Liverpool, United Kingdom

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

London, United Kingdom