Biomarker of Diabetic Retinopathy
A
Ashay D. Bhatwadekar, PhD, MPHARM
Primary Investigator
Enrolling By Invitation
18 years or above
All
Phase
N/A
192 participants needed
3 Locations
Brief description of study
What is the purpose of this study?
Diabetic retinopathy is characterized by damage to retinal blood vessels. At present, there is no diagnostic marker reflecting retinal vascular health. By studying RNA content (genetic material that makes proteins) in highly specialized cells in circulating blood resembling blood vessels, we will discover biomarker of diabetic retinopathy
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects will be recruited during their routine eye appointment visiting our clinics at one of the following facilities: (i) Glick Eye Institute, (ii) Springmill clinic, and (iii) Eskenazi Hospital Eye Clinic. Dr. Amir Hajrasouliha and study coordinators will help with patient identification and enrollment. After routine eye examination, the subject’s eligibility will be assessed, and the study will be discussed. For subjects who are eligible for the study, the study protocol will be discussed with the patient by a study investigator and clinic coordinator. If the subject agrees, they will be enrolled in the study during the same appointment.
Detailed description of study
What will happen during the study?
The following procedures will be performed:
- Wide fundus photography
The 200º Ultra-Wide Fundus images should be obtained first and acquired after pupillary dilation. Pupil dilation should be checked prior to imaging, and if a pupil is not dilated to at least 5 mm, reapplication of dilating drops should be considered. - Optical Coherence Tomography angiography
It is a non-invasive technique of imaging the retina.
As part of the study for diabetic patients with moderate NPDR, severe NPDR, and PDR - Fluorescein angiography
Fluorescein dye is a yellow color dye injected into a vein in the arm/hand. The dye visualizes the blood vessels in the retina, which will be recorded by photographs. Fluorescein angiography is a standard of care for individuals with moderate NPDR, severe PDR and PDR, therefore test charges will be billed to the patient’s insurance. - Collection of blood and RNA sequencing: A single blood draw of 100-120 ml will be performed in blood collection tubes. A highly purified fraction of CD34+ cells will be isolated using a cell sorter. We will perform RNA sequencing at the core facilities of Indiana University School of Medicine.
As part of the study for all individuals participating in the study - Collection of blood and RNA sequencing: A single blood draw of 100-120 ml will be performed in blood collection tubes. A highly purified fraction of CD34+ cells will be isolated using a cell sorter. We will perform RNA sequencing at the core facilities of Indiana University School of Medicine.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Diabetic Retinopathy
-
Age: 18 years or above
-
Gender: All
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 maculardegeneration (AMD), glaucoma, uveitis, and branched or central vein occlusion.
Updated on
31 Mar 2025.
Study ID: OPTH-IIR-MIRNA, 11656
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