Clinical Trials in France / NCT06924021
Recruiting
Observational
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
NCT06924021 · tracked via the Priya Life Science France tracker
Condition(s) studied
Age-Related Macular Degeneration
Investigational drug(s) / intervention(s)
Retinal Imaging
Retinal Imaging: Eligible participants will undergo one retinal imaging session of both eyes for the following: * Single field stereo color fundus photography (cFP) - pre and post dilation * Macular spectral domain-optical coherence tomography (SD-OCT)
Study summary
1000 participants from up to 25 international locations who are at least 50 years old with either healthy eyes or a diagnosis of Age-Related Macular Degeneration (AMD) will be consented to provide images of their eyes for a new dataset. This dataset is an important step in developing an Artificial Intelligence (AI) based screening tool for AMD.
Eligibility
Inclusion Criteria:
* Participants greater than or equal to 50 years of age at time of signing Informed Consent Form
* Willing to comply with all study procedures and sign the Informed Consent Form (ICF)
* Individuals with normal healthy eyes or diagnosed with any stage of Age-Related Macular Degeneration (treatment naïve patients with early, intermediate, or late AMD). The diagnosis and eligibility review will be confirmed by Central Reading Center.
Exclusion Criteria:
* Therapeutic treatment for any type of AMD, in either eye. Supplements, such as AREDS2 formula, are allowed.
* Unable to acquire adequate quality images, as evaluated by the Central Reading Center
* Severe vision loss requiring urgent surgery
* Contraindicated for acquiring retinal images due to narrow anterior chamber angles or hypersensitivity to light
* A systemic or ocular condition that in the opinion of the Investigator would preclude participation in the study
* Unwilling to sign informed consent form
* Currently or previously enrolled in an interventional AMD clinical trial
Primary outcome measure(s)
- AMD Classification by Participant Count — up to 18 months
A meticulously curated and diverse Benchmark dataset, featuring reference standard level 1 classification and annotated images for a wide range of AMD phenotypes is the primary outcome. Diversity of the dataset will in part be measured by classifying AMD status. The goal is to have: * 20% participants with no AMD * 30% participants with Early AMD * 30% participants with Intermediate AMD * 10% participants with Geographic Atrophy (GA) * 10% participants with Neovascular age-related macular degeneration (nAMD) - Geographic Location by Participant Count — up to 18 months
A meticulously curated and diverse Benchmark dataset, featuring reference standard level 1 classification and annotated images for a wide range of AMD phenotypes is the primary outcome. Diversity of the dataset will in part be measured by geographic location. 1000 participants from up to 25 global sites will be included.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Bergstrom Eye Research LLC | Fargo | North Dakota | Recruiting |
| Erie Retina Research | Erie | Pennsylvania | Recruiting |
| Retina Foundation of the Southwest | Dallas | Texas | Recruiting |
| Valley Retina Institute | McAllen | Texas | Recruiting |
| Retina Consultants of Texas (Houston) | The Woodlands | Texas | Recruiting |
| University of Utah - John A. Moran Eye Center | Salt Lake City | Utah | Recruiting |
| University Station Eye Care Clinic | Madison | Wisconsin | Recruiting |
| Charles Research Center | Buenos Aires | Argentina | Not Yet Recruiting |
| Adelaide Eye and Retina Centre | Adelaide | Australia | Not Yet Recruiting |
| Centre Hospialier Intercommunal de Paradis (Centre Monticelli Paradis) | Marseille | France | Not Yet Recruiting |
| University of Bonn - Department of Ophthalmology | Bonn | Germany | Not Yet Recruiting |
| Sankara Nethralaya, Medical Research Foundation | Chennai | Tamil Nadu | Recruiting |
| Aravind Eye Hospital | Chennai | Tamil Nadu | Recruiting |
| Aga Khan University | Karachi | Pakistan | Recruiting |
Other trials for the same condition
An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06924021 on ClinicalTrials.gov ↗ ← All trials in France