Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)

Last updated: May 13, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Myopic Macular Degeneration

Macular Degeneration

Treatment

Retinal Imaging

Clinical Study ID

NCT06924021
2025-0059
Protocol Version 3/14/2025
A536070
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • Participants greater than or equal to 50 years of age at time of signing InformedConsent 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-RelatedMacular Degeneration (treatment naïve patients with early, intermediate, or lateAMD). The diagnosis and eligibility review will be confirmed by Central ReadingCenter.

Exclusion

Exclusion Criteria:

  • Therapeutic treatment for any type of AMD, in either eye. Supplements, such asAREDS2 formula, are allowed.

  • Unable to acquire adequate quality images, as evaluated by the Central ReadingCenter

  • Severe vision loss requiring urgent surgery

  • Contraindicated for acquiring retinal images due to narrow anterior chamber anglesor hypersensitivity to light

  • A systemic or ocular condition that in the opinion of the Investigator wouldpreclude participation in the study

  • Unwilling to sign informed consent form

  • Currently or previously enrolled in an interventional AMD clinical trial

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Retinal Imaging
Phase:
Study Start date:
May 12, 2025
Estimated Completion Date:
November 30, 2026

Study 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).

Connect with a study center

  • Aravind Eye Hospital

    Chennai, Tamil Nadu 641014
    India

    Site Not Available

  • Sankara Nethralaya, Medical Research Foundation

    Chennai, Tamil Nadu 600006
    India

    Site Not Available

  • Bergstrom Eye Research LLC

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Retina Foundation of the Southwest

    Dallas, Texas 75231
    United States

    Site Not Available

  • University Station Eye Care Clinic

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

  • Wisconsin Reading Center

    Madison, Wisconsin 53717
    United States

    Site Not Available

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