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

NCT07084883 | Recruiting DMC

• 2 other identifiers: 2024-01-iPredict-AMDR44EY031202
• Study Type: observational
• Target: 1,076
• Locations: 1 country
• Sites: 1

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)

Keywords

Screening; Prediction; age-related macular degeneration; AMD

Outcome Measures

Primary Outcomes (1)

• Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.

  Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.

  1 year or 2-year

Study Arms (1)

One group

One Cohort

Device: No intervention.

Interventions

No intervention. DEVICE

No intervention. Evaluate the automated AMD screening software.

One group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be carried at the primary care and general ophthalmology clinic. The total number of patients to be recruited is 1076. Subjects will be recruited during their routine ophthalmology visit, and each subject will be identified by their ophthalmologist as appropriate to take part in the study. After a short verbal explanation, the ophthalmologist may ask the subject to take part in the study. Patients will be recruited without selection by eye diagnosis from the clinics. Both males and females will be invited to participate. Patients will be over 50 since AMD is overwhelmingly a disease of this population. It is anticipated that the subjects will be of all races and ethnic origins, in line with our diverse clinic populations in New York city. Provided that they fit the study criteria, all subjects are invited to participate. However, we aim to recruit the majority as white ethnicity as AMD is a disease for predominantly white ethnicity.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• iHealthScreen Inc: lead
• National Institutes of Health (NIH): collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

iHealthScreen Inc.

Richmond Hill, New York, 11418, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Alauddin Bhuiyan, PhD

  iHealthScreen Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alauddin Bhuiyan

CONTACT

718-926-9000; bhuiyan@ihealthscreen.org

Fariha Nuha, BS (Comp. Biology)

CONTACT

718-912-0837; fariha@ihealthscreen.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 25, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after 5 years
• Access Criteria: To be enrolled in the NIH data sharing portal - dbGAP.

Locations

US (1)