Automated AI system for early detection of diabetic retinopathy

Pivotal Trial of Automated AI-based System for Early Diagnosis of Diabetic Retinopathy Using Retinal Color Imaging

This study will test whether the iPredict-DR AI software can find early diabetic retinopathy from retinal photos in adults with diabetes.

Quick facts

• Study type: Observational
• Enrollment: 922 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: iHealthScreen Inc (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Richmond Hill, New York)
• Trial ID: NCT07151001 on ClinicalTrials.gov

What this trial studies

This is a prospective observational study testing iPredict-DR, an artificial intelligence tool, for early detection of diabetic retinopathy in primary care and endocrinology clinic settings. Patients with diabetes will have retinal images captured and analyzed automatically by the software, with results compared to standard ophthalmic grading using the American Academy of Ophthalmology severity scale. The goal is to identify mild or early DR cases that might otherwise be missed before symptoms develop and to explore whether automated screening can be deployed in non‑eye‑care clinics. Broad prospective screening could help prioritize ophthalmology referrals and increase access to DR detection.

Who should consider this trial

Good fit: Adults aged 22 or older with diabetes (A1C ≥ 6.5) who do not already have a diagnosis of diabetic retinopathy and can provide informed consent are eligible.

Not a fit: Patients who already have diagnosed diabetic retinopathy, macular edema, active vision problems needing eye care, whose images were used to train the device, or who are enrolled in other investigational eye studies are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the software could help catch diabetic retinopathy earlier and make screening more accessible in primary care clinics.

How similar studies have performed: Similar AI-based retinal screening systems have been validated in prior studies and some have received regulatory clearance, showing that this approach can work in practice.

Eligibility criteria

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.

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

Conditions: Diabetes, Diabetic Retinopathy, Early Diagnosis, Screening