Diabetic RetinopathyNCT03694145
Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Charles Drew University of Medicine and Science at 3 sites in United States.
Trial summary
The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Macular Edema
- What is being tested?
- In-Person Eye Examination
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Oct 2018to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises patients with Type I or Type II diabetes who are normally seen at LACDHS clinics and usually screened for diabetic retinopathy via teleretinal screening.
Who may be able to join
- Patients diagnosed with Type I or Type II Diabetes
- Patients who are over the age of 18 years
- Patients who have not previously been seen in the current year by the LACDHS Teleretinal Diabetic Retinopathy Screening Program and Reading Center
- Patients whose teleretinal screening exam images yield readable results
Who cannot join
- Patients under the age of 18 years
- Patients with gestational diabetes
- Patients who have previously been seen in the current year by LACDHS's Teleretinal Diabetic Retinopathy Screening Program and Reading Center
- Patients whose teleretinal screening exam images do not yield readable results, as gradable images are needed for later comparison against ophthalmologist reads.
- Previously eligible patients who do not return for an in-person eye exam within 3 months of receiving a teleretinal screening (In order for the results of the teleretinal screening and in-person eye examinations to yield similar information, patients who do not return for their in-person eye exam within 3 months of their teleretinal screening will not be able to remain in the study. This is because significant eye changes not documented by the teleretinal screening may occur after a 3-month period).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Los Angeles Department of Public Health
Los Angeles, California, 90012
University of California - Los Angeles
Los Angeles, California, 90024
Charles R. Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program.
Read the detailed description
This study represents the third aim of a grant with five aims. The study will compare and evaluate the predictive accuracy of: (a) machine learning models developed to grade diabetic retinopathy and assess the presence or absence of diabetic macular edema and (b) the assessments of optometrist readers, both from digital retinal images, against standard of care dilated retinal examinations by board-certified ophthalmologists and/or retinal-specialty fellows for 300 diabetic patients utilizing a Los Angeles County reading center.
For the study, the investigators will recruit 300-500 eligible diabetic patients for in-person eye examinations performed by board certified ophthalmologists and/or retinal-specialty fellows at Los Angeles County reading centers. The study will take place over the course of two visits: a teleretinal screening and an in-person eye examination.
The in-person dilated eye examinations that the study participants will participate in and be compensated for follow the usual standard of care that patients receive in a setting that does not utilize teleretinal screening. Yearly dilated eye examinations are standard of care for all persons with diabetes.
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Being tested
- In-Person Eye Examination
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Eye ExaminationOther
Dilated in-person eye examination by a board-certified ophthalmologist or retinal fellow.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients w. risk of retinopathy | The 300-500 patients to be enrolled for the study are diabetic patients normally seen by the Los Angeles County Department of Health Services (LACDHS) Teleretinal Diabetic Retinopathy Screening Program and Reading Center. In addition to receiving their recommended LACDHS annual teleretinal screening, for the study, participants will receive an additional in-person eye examination. Receives: Other: In-Person Eye Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients accurately diagnosed with retinopathy
Proportion of patients accurately diagnosed with retinopathy using machine learning versus proportion accurately diagnosed by teleretinal screening optometrists with in-person eye examinations by ophthalmologists used as a gold standard.
Measured: 11/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start25 Oct 2018
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM), Los Angeles County Department of Public Health, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Omolola Ogunyemi, PhD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694145
- Sponsor's protocol ID
- 1218589-3
- Other IDs
- R01LM012309
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2018
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images
- ClinicalTrials.gov ID
- NCT03694145
- Acronym / sponsor ID
- 1218589-3
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM), Los Angeles County Department of Public Health, University of California, Los Angeles
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Oct 2018 (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.
The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program.
Detailed description
This study represents the third aim of a grant with five aims. The study will compare and evaluate the predictive accuracy of: (a) machine learning models developed to grade diabetic retinopathy and assess the presence or absence of diabetic macular edema and (b) the assessments of optometrist readers, both from digital retinal images, against standard of care dilated retinal examinations by board-certified ophthalmologists and/or retinal-specialty fellows for 300 diabetic patients utilizing a Los Angeles County reading center.
For the study, the investigators will recruit 300-500 eligible diabetic patients for in-person eye examinations performed by board certified ophthalmologists and/or retinal-specialty fellows at Los Angeles County reading centers. The study will take place over the course of two visits: a teleretinal screening and an in-person eye examination.
The in-person dilated eye examinations that the study participants will participate in and be compensated for follow the usual standard of care that patients receive in a setting that does not utilize teleretinal screening. Yearly dilated eye examinations are standard of care for all persons with diabetes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients w. risk of retinopathy | – | Other: In-Person Eye ExaminationThe 300-500 patients to be enrolled for the study are diabetic patients normally seen by the Los Angeles County Department of Health Services (LACDHS) Teleretinal Diabetic Retinopathy Screening Program and Reading Center. In addition to receiving their recommended LACDHS annual teleretinal screening, for the study, participants will receive an additional in-person eye examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises patients with Type I or Type II diabetes who are normally seen at LACDHS clinics and usually screened for diabetic retinopathy via teleretinal screening.
Key inclusion criteria (4 listed)
- Patients diagnosed with Type I or Type II Diabetes
- Patients who are over the age of 18 years
- Patients who have not previously been seen in the current year by the LACDHS Teleretinal Diabetic Retinopathy Screening Program and Reading Center
- Patients whose teleretinal screening exam images yield readable results
Key exclusion criteria (5 listed)
- Patients under the age of 18 years
- Patients with gestational diabetes
- Patients who have previously been seen in the current year by LACDHS's Teleretinal Diabetic Retinopathy Screening Program and Reading Center
- Patients whose teleretinal screening exam images do not yield readable results, as gradable images are needed for later comparison against ophthalmologist reads.
- Previously eligible patients who do not return for an in-person eye exam within 3 months of receiving a teleretinal screening (In order for the results of the teleretinal screening and in-person eye examinations to yield similar information, patients who do not return for their in-person eye exam within 3 months of their teleretinal screening will not be able to remain in the study. This is because significant eye changes not documented by the teleretinal screening may occur after a 3-month period).
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 |
|---|---|---|
| In-Person Eye ExaminationDilated in-person eye examination by a board-certified ophthalmologist or retinal fellow. | Other | Diabetic patients w. risk of retinopathy |
Primary outcome
Proportion of patients accurately diagnosed with retinopathy
Time frame: 11/2022
Proportion of patients accurately diagnosed with retinopathy using machine learning versus proportion accurately diagnosed by teleretinal screening optometrists with in-person eye examinations by ophthalmologists used as a gold standard.
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 22 Oct 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.
Omolola Ogunyemi, PhD principal investigator
Charles Drew University of Medicine and Science
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 Diabetic Macular Edema, run by Charles Drew University of Medicine and Science 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 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?
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?
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?
Proportion of patients accurately diagnosed with retinopathy (time frame: 11/2022). 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 22 Oct 2026.