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Biomarker of Diabetic Retinopathy

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Indiana University

Status

Enrolling

Conditions

Diabetic Retinopathy

Treatments

Other: Blood draw

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

192 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 macular degeneration (AMD), glaucoma, uveitis, and branched or central vein occlusion.

Trial design

192 participants in 6 patient groups

Healthy Control
Treatment:
Other: Blood draw
Diabetes but no retinopathy
Treatment:
Other: Blood draw
Mild non proliferative diabetic retinopathy
Treatment:
Other: Blood draw
Moderate non proliferative diabetic retinopathy
Treatment:
Other: Blood draw
Severe non proliferative diabetic retinopathy
Treatment:
Other: Blood draw
Proliferative diabetic retinopathy
Treatment:
Other: Blood draw

Trial contacts and locations

3

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Central trial contact

Amir R Hajrasouliha, MD; Ashay D Bhatwadekar, PhD, RPh

Data sourced from clinicaltrials.gov

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