Actively Recruiting
Biomarker of Diabetic Retinopathy
Led by Indiana University · Updated on 2025-05-01
192
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Diabetic retinopathy (DR) is a complication of diabetes where the blood vessels in the retina do not function properly, causing poor oxygen and nutrient supply to the eye tissue. This condition can lead to the growth of abnormal blood vessels and affect normal vision. Researchers are studying specialized blood cells to find markers that can indicate the health of retinal blood vessels in people with DR. Participants in this observational study will have blood samples drawn to analyze circulating angiogenic cells for RNA signatures, inflammatory markers, and epigenetic changes. The study includes groups with different stages of diabetic retinopathy, ranging from healthy controls to proliferative DR. Blood samples and imaging tests will be conducted at the start and during a follow-up visit scheduled between 3 to 5 years later. During the study, participants will undergo imaging procedures such as wide-field fundus photography, fluorescein angiography, and optical coherence tomography angiography to assess retinal changes. Researchers will track changes in RNA expression, inflammation markers, vessel density, retinal thickness, and clinical scoring of DR severity. The total participation duration includes the baseline visit and a follow-up visit between 3 and 5 years after enrollment.
CONDITIONS
Brief Title
Biomarker of Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to cooperate with imaging procedures
- Established diagnosis of type 2 diabetes
- No history of panretinal photocoagulation (PRP)
- No treatment with intravitreal agents in the past 12 months
You will not qualify if you...
- Previous or current malignancy
- Acute or chronic infection such as HIV, hepatitis B or C, or tuberculosis
- History of cerebral vascular accident or cerebral vascular procedure
- Current pregnancy
- History of organ transplantation
- Presence of a graft
- Prior vitrectomy
- History of age-related macular degeneration, glaucoma, uveitis, or branched/central vein occlusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo blood draws and imaging procedures to assess diabetic retinopathy status at baseline.
1 visit (in-person)
Duration - 3 to 5 years
Participants are monitored with follow-up visits to collect blood samples and imaging data to observe changes in diabetic retinopathy over time.
1 follow-up visit between 3 to 5 years after baseline
Trial Site Locations
Total: 3 locations
1
Spring Mill Clinic
Carmel, Indiana, United States, 46920
Actively Recruiting
2
Eskenazi Eye Clinic
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Glick Eye Institute
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
A
Ashay D Bhatwadekar, PhD, RPh
A
Amir R Hajrasouliha, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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