iPredict: automated AI for early detection and prediction of late age-related macular degeneration
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
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1076 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | iHealthScreen Inc Industry-sponsored |
| Locations | 1 site (Richmond Hill, New York) |
| Trial ID | NCT07084883 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Richmond Hill, New York
- iHealthScreen Inc. — Richmond Hill, New York, United States (Recruiting)
Study contacts
- Principal investigator: Alauddin Bhuiyan, PhD — iHealthScreen Inc
- Study coordinator: Alauddin Bhuiyan
- Email: bhuiyan@ihealthscreen.org
- Phone: 718-926-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.