Status:
ACTIVE_NOT_RECRUITING
INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study
Lead Sponsor:
Stephen J. Kim, MD
Collaborating Sponsors:
Allergan
National Eye Institute (NEI)
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The central hypothesis is that inflammation mediators are biomarkers of both systemic diabetes and Diabetic Retinopathy (DR) progression in the aqueous and that sustained topical ketorolac application...
Detailed Description
Study goals include confirming inflammation mediators are biomarkers of both systemic diabetes and DR progression in the aqueous. Like the vitreous humor, the aqueous reflects localized ocular inflamm...
Eligibility Criteria
Inclusion
- Aim 1 Diabetic Arm Adult patients age 18 years or greater with type II diabetes.
- Aim 1 Nondiabetic Control Arm age-matched patients without diabetes who are undergoing unilateral vitrectomy surgery for non-inflammatory conditions such as epiretinal membrane or macular hole.
- Aim 2 Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and HbA1c ≥ 8.
Exclusion
- Aim 1 Diabetic Arm
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04505566
Start Date
November 9 2020
End Date
December 1 2025
Last Update
September 26 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232