Diabetic Retinopathy (DR)NCT07844317
Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
An observational study of Diabetic Retinopathy (DR), run by Digital Diagnostics, Inc. at 1 site in United States.
Trial summary
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy (DR)
- What is being tested?
- SaMD intended for the detection of diabetic retinopathy in adults with diabetes. and An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic adult population with no previous diagnosis of DR
Who may be able to join
- 22 years of age or older
- Diagnosis of DM
- Ability to understand and willing to sign a written ICF
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rovia Site Network
Jacksonville, Florida, 32216
Regional Director of Operations, 904-735-5466, margot.wrenn@roviaclinical.com
About this study
Official title: A Multicenter, Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Automated System for Detecting Diabetic Retinopathy Using a Fundus Camera
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
- Conditions
- Diabetic Retinopathy (DR)
- Being tested
- SaMD intended for the detection of diabetic retinopathy in adults with diabetes., An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.
- Keywords
- AI-enabled, Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.Device
Also called AI/ML, SaMD
SaMD to detect diabetic retinopathy
| Study group | Role | What they receive |
|---|---|---|
| Single arm, non-randomized cohort | Adult, 22 years or older with a diagnosis of diabetes Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start24 Aug 2026
- Primary completion30 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Digital Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844317
- Sponsor's protocol ID
- PRO-CLN-009
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Automated System for Detecting Diabetic Retinopathy Using a Fundus Camera
- ClinicalTrials.gov ID
- NCT07844317
- Acronym / sponsor ID
- PRO-CLN-009
- Conditions
- Diabetic Retinopathy (DR)
- Keywords
- AI-enabled, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Digital Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, non-randomized cohort | – | 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.Adult, 22 years or older with a diagnosis of diabetes |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic adult population with no previous diagnosis of DR
Key inclusion criteria (3 listed)
- 22 years of age or older
- Diagnosis of DM
- Ability to understand and willing to sign a written ICF
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaMD intended for the detection of diabetic retinopathy in adults with diabetes.No significant difference to other SaMDs for the detection of DR that are commercialized. | Device | 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.Also: AI/ML, SaMDSaMD to detect diabetic retinopathy | Device | Single arm, non-randomized cohort |
Primary outcome
Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy (DR), run by Digital Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Singh Singh (7633702127, singh@digitaldiagnostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 3 Nov 2026.