Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration

The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.

NCT Number	NCT07084883
Lead Sponsor	iHealthScreen Inc Collaborators: National Institutes of Health (NIH), National Eye Institute (NEI)
Conditions	Age-related Macular Degeneration (AMD)
Enrollment	1,076 participants
Start Date	2024-08-01
Primary Completion	2027-07-31 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-28