Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06924021

Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)

Status
Recruiting
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
University of Wisconsin, Madison · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

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.

Detailed description

Age-related macular degeneration (AMD) is a leading cause of blindness in the world. The early and intermediate stages of AMD progress to late stage resulting in vision loss due to either geographic atrophy or neovascular AMD. Preventive measures to reduce treatment burden and prevent blindness are important. While there are no approved therapies for early disease, active research is underway. However, advancing therapeutic trials for AMD prevention remains challenging due to the lack of primary care involvement in early-stage AMD diagnosis. A clear need exists for a reliable screening tool, deployable in optometry or primary care facilities to identify those with an early stage of disease. While an Artificial Intelligence (AI) based screening tool would be an ideal solution, there are obstacles to its prospective validation due to difficulty in enrolling sufficient cases in a screening environment. A key step towards promoting this field lies in collecting a diverse dataset of multimodal imaging and providing a reference standard level 1 classification from a wide array of patients with AMD. Having such a benchmark dataset available for research purposes will empower the development and validation of AI models for AMD. This data can serve as the much-sought pathway to the rapid development of screening models, facilitating the referral of patients with the appropriate disease spectrum, and ultimately leading to the prevention of late AMD. This is a prospective, cross-sectional, multi-center, observational study to collect and develop a meticulously curated and diverse AMD benchmark dataset, featuring reference standard level 1 classification and comprehensive annotation of images. Study procedures include: * Patient history: demographics (age, sex, ethnicity, race), smoking history, family history of AMD * Physical exam: height and weight * Snellen best-corrected visual acuity (BCVA) * AMD classification (Beckman scale) 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) Due to the need for diversity in the dataset, sites need to represent a wide array of geographical locations. In addition, balancing will be done on enrolled participants with or without AMD including age, sex, and AMD level (worse eye selected as study eye).

Conditions

Interventions

TypeNameDescription
OTHERRetinal ImagingEligible 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)

Timeline

Start date
2025-05-12
Primary completion
2026-11-01
Completion
2026-11-01
First posted
2025-04-11
Last updated
2026-03-27

Locations

14 sites across 7 countries: United States, Argentina, Australia, France, Germany, India, Pakistan

Source: ClinicalTrials.gov record NCT06924021. Inclusion in this directory is not an endorsement.