NCT07844317 Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
| NCT ID | NCT07844317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Digital Diagnostics, Inc. |
| Condition | Diabetic Retinopathy (DR) |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2026-08-24 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2026-08-24 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Eligibility Criteria
Inclusion Criteria: * 22 years of age or older * Diagnosis of DM * Ability to understand and willing to sign a written ICF Exclusion Criteria: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07844317 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Diabetic Retinopathy (DR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07844317 currently recruiting?
Yes, NCT07844317 is actively recruiting participants. Contact the research team at singh@digitaldiagnostics.com for enrollment information.
Where is the NCT07844317 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07844317 clinical trial?
NCT07844317 is sponsored by Digital Diagnostics, Inc.. The trial plans to enroll 800 participants.