Diabetic RetinopathyNCT05079399
Biomarker of Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Indiana University at 3 sites in United States.
Trial summary
Diabetic retinopathy (DR) is a complication of diabetes in which blood vessels supplying blood to the back of the eye (retina) are dysfunctional. This can lead to an improper supply of oxygen and nutrients to the retinal tissue, or it may trigger the formation of new blood vessels in response to the oxygen/nutrient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Blood draw
- How many people
- 192 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2022to 30 Jun 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
- Adult, Older adult
Study population: We will recruit type 2 diabetes individuals with different severities of diabetic retinopathy and non-diabetes controls.
Who may be able to join
- Ability to cooperate with imaging procedures.
- Health status: established type 2 diabetes
- No history of panretinal photocoagulation (PRP)
- No history of treatment with intravitreal agents for past 12 months
Who cannot join
- Previous or current malignancy
- Acute or chronic infection (HIV, hepatitis B or C, tuberculosis)
- Cerebral vascular accident or cerebral vascular procedure
- Current pregnancy
- History of organ transplantation
- Presence of a graft (to avoid any effect of the graft)
- History of previous vitrectomy
- Subjects with a history of age-related macular degeneration age-related macular degeneration (AMD), glaucoma, uveitis, and branched or central vein occlusion.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Spring Mill Clinic
Carmel, Indiana, 46920
Amir R Hajrasouliha, MD, amhajras@iu.edu
- Recruiting
Eskenazi Eye Clinic
Indianapolis, Indiana, 46202
Amir R Hajrasouliha, MD, amhajras@iu.edu
- Recruiting
Glick Eye Institute
Indianapolis, Indiana, 46202
Amir R Hajrasouliha, MD, 3179441154, amhajras@iu.edu
About this study
Diabetic retinopathy (DR) is a complication of diabetes in which blood vessels supplying blood to the back of the eye (retina) are dysfunctional. This can lead to an improper supply of oxygen and nutrients to the retinal tissue, or it may trigger the formation of new blood vessels in response to the oxygen/nutrient deficiency. Ultimately affecting the normal vision. There is no known marker that will provide information on the health status of retinal blood vessels. Using highly specialized cells in the blood, this study will try to discover a marker of DR.
- Conditions
- Diabetic Retinopathy
- Being tested
- Blood draw
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Blood samples will be collected via venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Not described Receives: Other: Blood draw | |
| Diabetes but no retinopathy | Not described Receives: Other: Blood draw | |
| Mild non proliferative diabetic retinopathy | Not described Receives: Other: Blood draw | |
| Moderate non proliferative diabetic retinopathy | Not described Receives: Other: Blood draw | |
| Severe non proliferative diabetic retinopathy | Not described Receives: Other: Blood draw | |
| Proliferative diabetic retinopathy | Not described Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants
Measured: Baseline and change in RNA signature in follow up visit (between 3-5 years)
Surface marker expression of inflammatory markers using flow cytometry
Measured: Baseline
miRNA expression
Measured: Baseline
Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy
Measured: Baseline
Secondary outcomes (4)
Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography
The scoring will be between 10 (no retinopathy) and 85 (advanced proliferative diabetic retinopathy). Higher score means worst outcome
Measured: Baseline and follow up visit (between 3-5 years)
Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA)
Measured: Baseline and follow up visit (between 3-5 years)
Change in vessel density in optical coherence tomography angiography (OCT-A)
Measured: Baseline and follow up visit (between 3-5 years)
Change in retinal thickness in optical coherence tomography angiography (OCT-A)
Measured: Baseline and follow up visit (between 3-5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Jan 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 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.
- More trials run by Indiana 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashay Bhatwadekar, PhD, RPh, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079399
- Sponsor's protocol ID
- 11656
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2021
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05079399
- Acronym / sponsor ID
- 11656
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Oct 2021 (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.
Diabetic retinopathy (DR) is a complication of diabetes in which blood vessels supplying blood to the back of the eye (retina) are dysfunctional. This can lead to an improper supply of oxygen and nutrients to the retinal tissue, or it may trigger the formation of new blood vessels in response to the oxygen/nutrient deficiency. Ultimately affecting the normal vision. There is no known marker that will provide information on the health status of retinal blood vessels. Using highly specialized cells in the blood, this study will try to discover a marker of DR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Other: Blood draw |
| Diabetes but no retinopathy | – | Other: Blood draw |
| Mild non proliferative diabetic retinopathy | – | Other: Blood draw |
| Moderate non proliferative diabetic retinopathy | – | Other: Blood draw |
| Severe non proliferative diabetic retinopathy | – | Other: Blood draw |
| Proliferative diabetic retinopathy | – | Other: Blood draw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We will recruit type 2 diabetes individuals with different severities of diabetic retinopathy and non-diabetes controls.
Key inclusion criteria (4 listed)
- Ability to cooperate with imaging procedures.
- Health status: established type 2 diabetes
- No history of panretinal photocoagulation (PRP)
- No history of treatment with intravitreal agents for past 12 months
Key exclusion criteria (8 listed)
- Previous or current malignancy
- Acute or chronic infection (HIV, hepatitis B or C, tuberculosis)
- Cerebral vascular accident or cerebral vascular procedure
- Current pregnancy
- History of organ transplantation
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 |
|---|---|---|
| Blood drawBlood samples will be collected via venipuncture | Other | Diabetes but no retinopathy, Healthy Control, Mild non proliferative diabetic retinopathy, Moderate non proliferative diabetic retinopathy, Proliferative diabetic retinopathy, Severe non proliferative diabetic retinopathy |
Primary outcome
mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants
Time frame: Baseline and change in RNA signature in follow up visit (between 3-5 years)
Surface marker expression of inflammatory markers using flow cytometry
Time frame: Baseline
miRNA expression
Time frame: Baseline
Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy
Time frame: Baseline
4 secondary outcomes
Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography
Time frame: Baseline and follow up visit (between 3-5 years)
Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA)
Time frame: Baseline and follow up visit (between 3-5 years)
Change in vessel density in optical coherence tomography angiography (OCT-A)
Time frame: Baseline and follow up visit (between 3-5 years)
Change in retinal thickness in optical coherence tomography angiography (OCT-A)
Time frame: Baseline and follow up visit (between 3-5 years)
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 23 Jul 2026.
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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.
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, run by Indiana University 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 8 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 23 Jul 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?
Contact Ashay D Bhatwadekar, PhD, RPh (3172785075, abhatwad@iupui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants (time frame: Baseline and change in RNA signature in follow up visit (between 3-5 years)). The study lists 4 primary outcomes in all. 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 23 Jul 2026.