Clinical trial Recruiting at 1 site Observational Ages 50 and up

iPredict: automated AI for early detection and prediction of late age-related macular degeneration

Official title: Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration in Ophthalmology and Primary Care Settings

Run by iHealthScreen Inc · NCT07084883 · Data updated 2026-11-12

iPredict will be tried to detect early signs and predict the risk of late AMD using non-dilated eye photos taken in primary care or general ophthalmology offices for adults without a prior AMD diagnosis.

More Age-Related Macular Degeneration (AMD) trials

Quick facts

Study typeObservational
Ages50 Years and up
SexAll
Enrollment1076 (estimated)
SponsoriHealthScreen Inc
Industry-sponsored
Locations1 site (Richmond Hill, New York)
StatusRecruiting
StartedAugust 1, 2024
Main results expectedJuly 31, 2027
Study endsAugust 31, 2027
Registry record updatedNovember 6, 2026
Trial IDNCT07084883 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults without a prior diagnosis of AMD who can provide informed consent and have non-dilated retinal photographs taken at a participating primary care or general ophthalmology office.

Probably not a fit

People already diagnosed with AMD, currently under treatment for retinal disease, or unable to give informed consent are unlikely to benefit from participation.

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

What this trial studies

This observational pivotal trial tests iPredict, an automated AI system that analyzes non-dilated fundus photos taken in primary care and general ophthalmology settings. Images will be captured using an FDA-approved DRSPlus fundus camera and uploaded securely to the cloud for automated analysis. The AI outputs will be validated prospectively against optical coherence tomography (OCT) scans and color fundus images to determine diagnostic and predictive accuracy for late AMD. Individuals already diagnosed with AMD or receiving retinal treatment are excluded, and prior comparisons versus ophthalmologist reads have shown sufficient accuracy to justify this validation.

Why it matters

Potential benefit: If successful, iPredict could enable earlier detection and risk prediction of late AMD during routine visits, allowing earlier monitoring and referral to eye specialists.

How similar studies have gone: Automated AI screening has shown success for other retinal diseases and iPredict has demonstrated adequate accuracy versus ophthalmologist reads, but prospective validation against OCT for predicting late AMD is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent

Exclusion Criteria:

* Already diagnosed with AMD, unable to provide informed consent and currently under treatment of retinal disease.

Where it's running

  • iHealthScreen Inc.
    Richmond Hill, New York, United States
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.