Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy

NCT07844317 | Recruiting

• 1 other identifier: PRO-CLN-009
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.

Conditions

Diabetic Retinopathy (DR)

Keywords

AI-enabled; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy

  1-year

Study Arms (1)

Single arm, non-randomized cohort

Adult, 22 years or older with a diagnosis of diabetes

Device: SaMD intended for the detection of diabetic retinopathy in adults with diabetes.; Device: An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.

Interventions

SaMD intended for the detection of diabetic retinopathy in adults with diabetes. DEVICE

No significant difference to other SaMDs for the detection of DR that are commercialized.

Single arm, non-randomized cohort

An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes. DEVICE

SaMD to detect diabetic retinopathy

Also known as: AI/ML, SaMD

Single arm, non-randomized cohort

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic adult population with no previous diagnosis of DR

You may qualify if:

• years of age or older
• Diagnosis of DM
• Ability to understand and willing to sign a written ICF

You may not qualify if:

• Participants may be excluded if they have significant ocular conditions or prior ocular treatments that could interfere with retinal imaging or study assessments; are currently participating in another interventional ophthalmic clinical trial; have medical conditions that may affect study participation or data interpretation; are pregnant; or have contraindications to study-related imaging procedures.

Sponsors & Collaborators

• Digital Diagnostics, Inc.: lead

Study Sites (1)

Rovia Site Network

Jacksonville, Florida, 32216, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Audrey Singh Singh

CONTACT

7633702127; singh@digitaldiagnostics.com

Study Design

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

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 28, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)