Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)

March 25, 2026 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Not yet recruiting
        • Charles Research Center
        • Principal Investigator:
          • Patricio Schlottmann
  • Australia
      • Adelaide, Australia, 5000
        • Not yet recruiting
        • Adelaide Eye and Retina Centre
        • Principal Investigator:
          • Jagjit Gilhotra
        • Contact:
          • Phone Number: +61 8 8212 3022
  • France
      • Marseille, France, 13008
        • Not yet recruiting
        • Centre Hospialier Intercommunal de Paradis (Centre Monticelli Paradis)
        • Principal Investigator:
          • Francois Devin
  • Germany
      • Bonn, Germany, 53127
        • Not yet recruiting
        • University of Bonn - Department of Ophthalmology
        • Principal Investigator:
          • Kristina Pfau
        • Contact:
          • Phone Number: +49 228 28715505
  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600006
        • Recruiting
        • Sankara Nethralaya, Medical Research Foundation
        • Contact:
          • Phone Number: +91 44 2827 1616
        • Principal Investigator:
          • Muna Bhende
      • Chennai, Tamil Nadu, India, 641014
        • Recruiting
        • Aravind Eye Hospital
        • Principal Investigator:
          • Rodney Morris
        • Contact:
          • Phone Number: +91 44 4095 6100
  • Pakistan
      • Karachi, Pakistan, 74800
        • Recruiting
        • Aga Khan University
        • Principal Investigator:
          • Haroon Tayyab
  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Bergstrom Eye Research LLC
        • Contact:
          • Phone Number: 701-235-5200
        • Principal Investigator:
          • Lance Bergstrom
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Recruiting
        • Erie Retina Research
        • Contact:
          • Phone Number: 814-200-9152
        • Principal Investigator:
          • David Almeida
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Retina Foundation of the Southwest
        • Contact:
          • Phone Number: 214-363-3911
        • Principal Investigator:
          • Karl Csaky
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Valley Retina Institute
        • Contact:
          • Phone Number: 844-485-3202
        • Principal Investigator:
          • Victor Gonzalez
      • The Woodlands, Texas, United States, 77384
        • Recruiting
        • Retina Consultants of Texas (Houston)
        • Principal Investigator:
          • Charles Wykoff
        • Contact:
          • Phone Number: 713-524-3434
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah - John A. Moran Eye Center
        • Principal Investigator:
          • Steffen Schmitz-Valckenberg
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University Station Eye Care Clinic
        • Contact:
        • Principal Investigator:
          • Amitha Domalpally

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AMD Benchmark Imaging Dataset Cohort

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)
Other: 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)
Other Names:
  • Single field stereo color fundus photography
  • Macular spectral domain-optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMD Classification by Participant Count
Time Frame: 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)
up to 18 months
Geographic Location by Participant Count
Time Frame: 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.
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Amitha Domalpally, MD, PhD, UW School of Medicine and Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0059
  • A536070 (Other Identifier: UW Madison)
  • Protocol Version 3/14/2025 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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