NCT06924021

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started May 2025

Geographic Reach
7 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
May 2025Nov 2026

First Submitted

Initial submission to the registry

April 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

April 4, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

screeningartificial intelligenceAI

Outcome Measures

Primary Outcomes (2)

  • 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)

    up to 18 months

  • 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.

    up to 18 months

Study Arms (1)

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

Interventions

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)

Also known as: Single field stereo color fundus photography, Macular spectral domain-optical coherence tomography
AMD Benchmark Imaging Dataset Cohort

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Bergstrom Eye Research LLC

Fargo, North Dakota, 58103, United States

RECRUITING

Erie Retina Research

Erie, Pennsylvania, 16507, United States

RECRUITING

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

RECRUITING

Valley Retina Institute

McAllen, Texas, 78503, United States

RECRUITING

Retina Consultants of Texas (Houston)

The Woodlands, Texas, 77384, United States

RECRUITING

University of Utah - John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

RECRUITING

University Station Eye Care Clinic

Madison, Wisconsin, 53705, United States

RECRUITING

Charles Research Center

Buenos Aires, Argentina

NOT YET RECRUITING

Adelaide Eye and Retina Centre

Adelaide, 5000, Australia

NOT YET RECRUITING

Centre Hospialier Intercommunal de Paradis (Centre Monticelli Paradis)

Marseille, 13008, France

NOT YET RECRUITING

University of Bonn - Department of Ophthalmology

Bonn, 53127, Germany

NOT YET RECRUITING

Sankara Nethralaya, Medical Research Foundation

Chennai, Tamil Nadu, 600006, India

RECRUITING

Aravind Eye Hospital

Chennai, Tamil Nadu, 641014, India

RECRUITING

Aga Khan University

Karachi, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Amitha Domalpally, MD, PhD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wisconsin Reading Center

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 11, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations