Recruiting

Artificial Intelligence

Sponsor:

University of Wisconsin, Madison

Code:

NCT06924021

Conditions

Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Retinal Imaging

Study Details

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.

Conditions

Age-Related Macular Degeneration

Study ID

NCT06924021

Start date

May 12, 2025

Status verified date

Mar, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Interventions

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)

Primary outcome measure

  • AMD Classification by Participant Count [ Time Frame: up to 18 months ]
  • Geographic Location by Participant Count [ Time Frame: up to 18 months ]

Central Contacts and Locations

Central contacts

Wisconsin Reading Center

1-608-262-1334wrc.support@wisc.edu

Locations

Bergstrom Eye Research LLC

Recruiting

Fargo, North Dakota, United States, 58103

Contacts

701-235-5200

Principal Investigator:

Lance Bergstrom

Erie Retina Research

Recruiting

Erie, Pennsylvania, United States, 16507

Contacts

814-200-9152

Principal Investigator:

David Almeida

Retina Foundation of the Southwest

Recruiting

Dallas, Texas, United States, 75231

Contacts

214-363-3911

Principal Investigator:

Karl Csaky

Valley Retina Institute

Recruiting

McAllen, Texas, United States, 78503

Contacts

844-485-3202

Principal Investigator:

Victor Gonzalez

Retina Consultants of Texas (Houston)

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

713-524-3434

Principal Investigator:

Charles Wykoff

University of Utah - John A. Moran Eye Center

Recruiting

Salt Lake City, Utah, United States, 84132

Principal Investigator:

Steffen Schmitz-Valckenberg

University Station Eye Care Clinic

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Site PI

608-263-7171wrc.support@wisc.edu

Principal Investigator:

Amitha Domalpally

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • screening
  • artificial intelligence
  • AI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-03-27.