Diabetic RetinopathyNCT06343350
OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection
An observational study of Diabetic Retinopathy and Diabetes, run by Optain Health at 3 sites in United States.
Trial summary
In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetes
- What is being tested?
- OPTDR01 software application
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Type I or Type II diabetes that are eligible for Diabetic Retinopathy screening
Who may be able to join
- Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA):
- Age 22 or older
- Understand the study and volunteer to sign the informed consent
Who cannot join
- Unable to understand the study
- Unwilling to sign informed consent
- Indicate persistent vision loss, blurred vision, or floaters
- Previous diagnosis of macular edema, diabetic retinopathy (any level) proliferative retinopathy, radiation retinopathy, or retinal vein occlusion
- History of laser treatment of the retina or injections into either eye, or any history of retinal surgery
- Currently participating in another investigational eye study or actively receiving investigational product for diabetic retinopathy or diabetic macular edema
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- 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
- Known pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Gastro SB
Chula Vista, California, 91910
Gulf Coast Clinical Research
Houston, Texas, 77070
Triwest Research Associates
San Diego, California, 92108
About this study
Official title: Prospective Pilot Study to Assess the Usability and Feasibility of OPTDR01 as an Automated Diabetic Retinopathy Screening Tool
In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates.
A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR.
Read the detailed description
This study will be conducted to assess the feasibility of the OPTDR01 in detecting mtmDR and vtDR in frontline care settings in adults with a diagnosis of diabetes but no prior diagnosis of diabetic retinopathy. The study will inform the design of a large pivotal study in terms of expected disease prevalence, participant recruitment rate, data collection tools and study workflow.
Eligible participants will undergo the following:
- retinal imaging sessions of each eye with a fundus camera for OPTDR01 evaluation
- dilation with mydriatic agent
- fundus photography, macular optical coherence tomography (OCT) and red reflex exam of each eye for comparison.
A subset of participants will be invited to participate in a precision sub-study, during which multiple operators will image participant eyes with multiple cameras.
- Conditions
- Diabetic Retinopathy, Diabetes
- Being tested
- OPTDR01 software application
- Keywords
- Artificial Intelligence, Diabetic Retinopathy, SaMD, Screening
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTDR01 software applicationDevice
Retinal images will be sent to the OPTDR01 software application for mtmDR and vtDR detection
| Study group | Role | What they receive |
|---|---|---|
| Retinal imaging | Participants will undergo retinal imaging with and without mydriatic agent to dilate the pupils. Receives: Device: OPTDR01 software application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate of eligible participants at clinical site
Number of eligible participants that are enrolled on a weekly basis at a clinical site
Measured: Assessed weekly until study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Apr 2024
- Primary completion6 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optain Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global BioClinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343350
- Sponsor's protocol ID
- OPTDR01P
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study to Assess the Usability and Feasibility of OPTDR01 as an Automated Diabetic Retinopathy Screening Tool
- ClinicalTrials.gov ID
- NCT06343350
- Acronym / sponsor ID
- OPTDR01P
- Conditions
- Diabetic Retinopathy, Diabetes
- Keywords
- Artificial Intelligence, Diabetic Retinopathy, SaMD, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Optain HealthIndustry (pharma, biotech, devices)
- Collaborators
- Global BioClinical
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 2 Apr 2024 (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.
In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates.
A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR.
Detailed description
This study will be conducted to assess the feasibility of the OPTDR01 in detecting mtmDR and vtDR in frontline care settings in adults with a diagnosis of diabetes but no prior diagnosis of diabetic retinopathy. The study will inform the design of a large pivotal study in terms of expected disease prevalence, participant recruitment rate, data collection tools and study workflow.
Eligible participants will undergo the following:
- retinal imaging sessions of each eye with a fundus camera for OPTDR01 evaluation
- dilation with mydriatic agent
- fundus photography, macular optical coherence tomography (OCT) and red reflex exam of each eye for comparison.
A subset of participants will be invited to participate in a precision sub-study, during which multiple operators will image participant eyes with multiple cameras.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal imaging | – | Device: OPTDR01 software applicationParticipants will undergo retinal imaging with and without mydriatic agent to dilate the pupils. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Type I or Type II diabetes that are eligible for Diabetic Retinopathy screening
Key inclusion criteria (3 listed)
- Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA):
- Age 22 or older
- Understand the study and volunteer to sign the informed consent
Key exclusion criteria (9 listed)
- Unable to understand the study
- Unwilling to sign informed consent
- Indicate persistent vision loss, blurred vision, or floaters
- Previous diagnosis of macular edema, diabetic retinopathy (any level) proliferative retinopathy, radiation retinopathy, or retinal vein occlusion
- History of laser treatment of the retina or injections into either eye, or any history of retinal surgery
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 |
|---|---|---|
| OPTDR01 software applicationRetinal images will be sent to the OPTDR01 software application for mtmDR and vtDR detection | Device | Retinal imaging |
Primary outcome
Enrollment rate of eligible participants at clinical site
Time frame: Assessed weekly until study end
Number of eligible participants that are enrolled on a weekly basis at a clinical site
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 and Diabetes, run by Optain Health at 3 sites 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 9 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate of eligible participants at clinical site (time frame: Assessed weekly until study end). 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 27 Feb 2026.