Diabetic RetinopathySEENNCT05188703
Patient Navigator Intervention for Diabetic Retinopathy
A study testing Patient Navigation in people with Diabetic Retinopathy and Diabetic Blindness, run by Yale University at 1 site in United States.
Trial summary
This is a pilot study of a patient navigator intervention for people living with diabetes and at high risk of diabetic blindness. The investigators are assessing the feasibility and acceptability of the intervention in preparation for a clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Blindness
- What is being tested?
- Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Adults aged 18 and over
- Diagnosis of diabetes and record of diagnosis in YNHHS EPIC
- English-speaking
- No documented eye examination within 1 year of study enrollment
- High risk for diabetic retinopathy based on risk calculator evaluation
Who cannot join
- Documented eye exam in the past year
- Not high risk for diabetic retinopathy
- Diabetes diagnosis not recorded in EPIC
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Undiagnosed Diabetic Retinopathy: Using Participatory Science to Design an Intervention for Patients at High-Risk for Blindness
This is a pilot study of a patient navigator intervention for people living with diabetes and at high risk of diabetic blindness. The investigators are assessing the feasibility and acceptability of the intervention in preparation for a clinical trial.
Read the detailed description
Evidence-based treatment for Diabetic retinopathy (DR) established 30 years ago decreases the likelihood of blindness by 50%. Outcomes are even better now with emerging therapies and technology. Diabetes remains the leading cause of new cases of legal blindness. This study is significant because it investigates the gap between published guidelines and the population that continues to go blind despite well-established recommendations for screening. Our current model of screening for DR screens much of the population appropriately. There is an opportunity to improve DR screening by timely identification of persons at risk for preventable blindness. DR disproportionately impacts Non-Hispanic Blacks, Latinos, Native Americans, and lower socioeconomic communities. Racial and ethnic minorities are less likely to be screened for DR, have a higher prevalence of disease, and more severe disease. There is not a clear path toward decreasing these disparities beyond these data. This study addresses barriers to the implementation of evidenced-based treatment protocols by identifying modifiable patient and population-level challenges and building an intervention informed by community members and national data. It is a direct response to the "population health imperative" described by the National Academies of Science, Engineering, and Medicine. Our study answers the National Eye Institute's Strategic Plan request to evaluate disparities by identifying barriers that prevent optimal treatment. It is aligned with the NEI's mission to support research and training with respect to the preservation of sight. The National Institute on Minority Health and Health Disparities Research Framework provides the conceptual foundation for our work. Our proposal identifies facets of the biologic, built, and sociocultural environments of the national population with undiagnosed DR. The national analysis informs a local individual-level intervention that addresses determinants associated with DR screening. The scientific premise of this study is the forty percent of persons with diabetes not screened despite established sight-saving treatment, the known disparities in screening for DR, and the increased prevalence of sight-threatening DR in Black, Latino, Native, and lower income Americans.
Primary Objective The primary objective of this study is to design and pilot a patient navigator program to increase screening for DR in a high-risk population.
Secondary Objective To determine the feasibility and accessibility of a patient navigation program for persons at high-risk for DR.
- Conditions
- Diabetic Retinopathy, Diabetic Blindness
- Being tested
- Patient Navigation
- Keywords
- diabetic retinopathy, diabetic blindness, patient navigator
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Participants will be assigned to a patient navigator and will have quarterly appointments. Patient navigators will assist with access and coordination of medical care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Intervention consists of standard of care eye exam and enrollment in a patient navigation program. Receives: Behavioral: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant Who Had Baseline Eye Exam
The number of participants who had their baseline eye exam will be determined using the electronic health record
Measured: baseline
Percentage of Participants Who Completed a Follow-up Eye Exam 12-18 Months After Baseline Eye Exam
Percentage of participants who completed a follow-up eye exam 12-18 months after baseline eye exam will be determined using the electronic health record
Measured: up to 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start25 Jul 2022
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm study. All participants will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Kristen Nwanyanwu, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188703
- Sponsor's protocol ID
- 2000031731
- Other IDs
- 1K23EY030530-01
- Acronym
- SEEN
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2021
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make IPD available to other researchers.
Publications
Nwanyanwu KMJH, Nunez-Smith M, Gardner TW, Desai MM. Awareness of Diabetic Retinopathy: Insight From the National Health and Nutrition Examination Survey. Am J Prev Med. 2021 Dec;61(6):900-909. doi: 10.1016/j.amepre.2021.05.018. Epub 2021 Aug 21.
PubMed 34426057
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undiagnosed Diabetic Retinopathy: Using Participatory Science to Design an Intervention for Patients at High-Risk for Blindness
- ClinicalTrials.gov ID
- NCT05188703
- Acronym / sponsor ID
- SEEN / 2000031731
- Conditions
- Diabetic Retinopathy, Diabetic Blindness
- Keywords
- diabetic retinopathy, diabetic blindness, patient navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of a patient navigator intervention for people living with diabetes and at high risk of diabetic blindness. The investigators are assessing the feasibility and acceptability of the intervention in preparation for a clinical trial.
Detailed description
Evidence-based treatment for Diabetic retinopathy (DR) established 30 years ago decreases the likelihood of blindness by 50%. Outcomes are even better now with emerging therapies and technology. Diabetes remains the leading cause of new cases of legal blindness. This study is significant because it investigates the gap between published guidelines and the population that continues to go blind despite well-established recommendations for screening. Our current model of screening for DR screens much of the population appropriately. There is an opportunity to improve DR screening by timely identification of persons at risk for preventable blindness. DR disproportionately impacts Non-Hispanic Blacks, Latinos, Native Americans, and lower socioeconomic communities. Racial and ethnic minorities are less likely to be screened for DR, have a higher prevalence of disease, and more severe disease. There is not a clear path toward decreasing these disparities beyond these data. This study addresses barriers to the implementation of evidenced-based treatment protocols by identifying modifiable patient and population-level challenges and building an intervention informed by community members and national data. It is a direct response to the "population health imperative" described by the National Academies of Science, Engineering, and Medicine. Our study answers the National Eye Institute's Strategic Plan request to evaluate disparities by identifying barriers that prevent optimal treatment. It is aligned with the NEI's mission to support research and training with respect to the preservation of sight. The National Institute on Minority Health and Health Disparities Research Framework provides the conceptual foundation for our work. Our proposal identifies facets of the biologic, built, and sociocultural environments of the national population with undiagnosed DR. The national analysis informs a local individual-level intervention that addresses determinants associated with DR screening. The scientific premise of this study is the forty percent of persons with diabetes not screened despite established sight-saving treatment, the known disparities in screening for DR, and the increased prevalence of sight-threatening DR in Black, Latino, Native, and lower income Americans.
Primary Objective The primary objective of this study is to design and pilot a patient navigator program to increase screening for DR in a high-risk population.
Secondary Objective To determine the feasibility and accessibility of a patient navigation program for persons at high-risk for DR.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm study. All participants will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Patient NavigationIntervention consists of standard of care eye exam and enrollment in a patient navigation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 and over
- Diagnosis of diabetes and record of diagnosis in YNHHS EPIC
- English-speaking
- No documented eye examination within 1 year of study enrollment
- High risk for diabetic retinopathy based on risk calculator evaluation
Key exclusion criteria (3 listed)
- Documented eye exam in the past year
- Not high risk for diabetic retinopathy
- Diabetes diagnosis not recorded in EPIC
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 |
|---|---|---|
| Patient NavigationParticipants will be assigned to a patient navigator and will have quarterly appointments. Patient navigators will assist with access and coordination of medical care. | Behavioural | Intervention arm |
Primary outcome
Number of Participant Who Had Baseline Eye Exam
Time frame: baseline
The number of participants who had their baseline eye exam will be determined using the electronic health record
Percentage of Participants Who Completed a Follow-up Eye Exam 12-18 Months After Baseline Eye Exam
Time frame: up to 18 month
Percentage of participants who completed a follow-up eye exam 12-18 months after baseline eye exam will be determined using the electronic health record
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34426057Nwanyanwu KMJH, Nunez-Smith M, Gardner TW, Desai MM. Awareness of Diabetic Retinopathy: Insight From the National Health and Nutrition Examination Survey. Am J Prev Med. 2021 Dec;61(6):900-909. doi: 10.1016/j.amepre.2021.05.018. Epub 2021 Aug 21.
- Individual participant dataSharing planned: No. There are no plans to make IPD available to other researchers.
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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.
Kristen Nwanyanwu, MD, MHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Diabetic Retinopathy and Diabetic Blindness, run by Yale University 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 5 inclusion and 3 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 11 Mar 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?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participant Who Had Baseline Eye Exam (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188703, which also lists 1 linked publication.
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 11 Mar 2026.