Recruiting

iPredict

Sponsor:

iHealthScreen Inc

Code:

NCT07084883

Conditions

Age-related Macular Degeneration (AMD)

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

No intervention.

Study Details

Brief summary:

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.

Conditions

Age-related Macular Degeneration (AMD)

Study ID

NCT07084883

Start date

Aug 1, 2024

Status verified date

Aug, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1076 participants

Anticipated

Interventions and Outcome Measures

Arms

One group

One Cohort

Interventions

No intervention.

No intervention. Evaluate the automated AMD screening software.

Primary outcome measure

  • Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year. [ Time Frame: 1 year or 2-year ]

Central Contacts and Locations

Central contacts

Locations

iHealthScreen Inc.

Recruiting

Richmond Hill, New York, United States, 11418

Contacts

More Information

Sponsor

iHealthScreen Inc

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Keywords

  • Screening
  • Prediction
  • age-related macular degeneration
  • AMD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by iHealthScreen Inc on 2025-08-28.