Creating a dataset for Age-Related Macular Degeneration imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study involves 1000 participants aged 50 and older from up to 25 international locations, who will provide retinal images to create a benchmark dataset for Age-Related Macular Degeneration (AMD). The goal is to develop an Artificial Intelligence (AI) based screening tool that can identify early stages of AMD, which is crucial for preventing vision loss. Participants can either have healthy eyes or a diagnosis of AMD, and their images will be used to validate AI models for effective screening. The study aims to address the challenges in enrolling sufficient cases for prospective validation of these screening tools.

Why it matters

Who can join: the full rules

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

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• Bergstrom Eye Research LLC
  Fargo, North Dakota, United States Recruiting
• Erie Retina Research
  Erie, Pennsylvania, United States Recruiting
• Retina Foundation of the Southwest
  Dallas, Texas, United States Recruiting
• Valley Retina Institute
  McAllen, Texas, United States Recruiting
• Retina Consultants of Texas (Houston)
  The Woodlands, Texas, United States Recruiting

Study contacts

• Principal investigator: Amitha Domalpally, MD, PhD — UW School of Medicine and Public Health
• Study coordinator: Wisconsin Reading Center
• Email: wrc.support@wisc.edu
• Phone: 1-608-262-1334

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Predicting Risk of AMD Progression Using Imaging in Aging Eyes

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• C.001 for retinal degeneration: a first-in-human dose-escalation safety test

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• Central microperimetry and radial OCT in geographic atrophy

  We will test whether central microperimetry and radial OCT scans can more accurately measure how geographic atrophy progresses toward the fovea in people with or at risk for GA from age-related macular degeneration.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.