Recruiting

iPredict-DR

Sponsor:

iHealthScreen Inc

Code:

NCT07151001

Conditions

Diabetes

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

No intervention

Study Details

Brief summary:

In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict-DR, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR) in the primary care and endocrinology clinics. DR is one of the leading causes of blindness in the United States and other developed countries. Every individual with diabetes is at risk of DR. It does not show any symptoms until the disease is progressed to advanced stages. If the disease is caught at an early stage, it can be prevented, managed, or treated effectively. Currently, screening for DR is done by the Ophthalmologists, which is limited to areas with limited availability. This is also time-consuming and expensive. All of these can be complemented by automated screening and set up the screening in the primary care clinics.

Conditions

Diabetes

Diabetic Retinopathy

Study ID

NCT07151001

Start date

Jan 1, 2025

Status verified date

Aug, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age of Subjects: Patients ≥ 22 years of age.
  • Gender of Subjects: Both males and females will be invited to participate.
  • Subjects with diabetes (A1C level ≥ 6.5).
  • Subjects must be willing and are able to comply with clinic visit, understand the study-related procedures/provisions, and provide signed informed consent.

Exclusion Criteria:

  • Unable to understand the study, Our unable to or unwilling to sign the informed consent
  • Previously diagnosed with macular edema, any form of diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
  • participants who are experiencing persistent vision loss, blurred vision, or other vision problems that should be evaluated by an eye care provider
  • subjects whose retinal images were used in training, validating, or developing the device
  • Currently participating in another investigational eye study or actively receiving investigational product for DR or DME.
  • A condition that, in the opinion of the investigator, would preclude participation in the study;
  • Contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity.

Study Design

Enrollment

922 participants

Anticipated

Interventions and Outcome Measures

Arms

One Group

One Cohort

Interventions

No intervention

No intervention. Evaluate the automated DR screening software.

Primary outcome measure

  • mtmDR detected (Referable DR) OR mtmDR not detected (non-referable DR) [ Time Frame: 1-year or 2-year ]
  • The accuracy of the iPredict-DR software developed by iHealthScreen system in early diagnosis of DR using color retinal photos vs. that of human expert graders [ Time Frame: 1-year or 2-year ]

Central Contacts and Locations

Central contacts

Alauddin Bhuiyan

718-926-9000bhuiyan@ihealthscreen.org

Fariha Nuha, BS (Comp. Biology)

718-912-0837fariha@ihealthscreen.org

Locations

iHealthScreen Inc.

Recruiting

Richmond Hill, New York, United States, 11418

Principal Investigator:

Alauddin Bhuiyan

More Information

Sponsor

iHealthScreen Inc

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Keywords

  • Early Diagnosis
  • Screening

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 2025-09-02.