Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
ConditionAge-Related Macular Degeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity of Wisconsin, Madison
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Approximately 1000 participants from up to 25 sites in the United States, Europe, Asia, South America, Africa, and Australia will be enrolled and balanced by age, sex, and AMD level (worse eye selected as study eye). Every region listed above may not be represented and additional regions/countries not listed above may be included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Retinal Imaging
Other interventionEligible 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)
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: AMD Benchmark Imaging Dataset Cohort1 intervention
Trial outcomes
Primary outcomes
1
AMD Classification by Participant Count
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)
Time frame
up to 18 months2
Geographic Location by Participant Count
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.
Time frame
up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov