Clinical Research Directory
Browse clinical research sites, groups, and studies.
INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study
Sponsor: Stephen J. Kim, MD
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 reduces/suppresses those inflammatory mediators thereby reducing the progression of Diabetic Retinopathy.
Official title: INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy (INSPIRE) Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2020-11-09
Completion Date
2026-05
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
Ketorolac 0.45% ophthalmic solution
Ketorolac 0.45% ophthalmic solution 1 drop instilled in both eyes twice daily for 3 years in double-masked fashion.
Placebo - Preservative-free artificial tears
Preservative free artificial tears ophthalmic solution 1 drop instilled in both eyes twice daily for 3 years in double-masked fashion.
Aqueous PGE2 and inflammatory cytokines measurements
After topical anesthetic, antibiotic and 5% povidone-iodine application, a 30 gauge needle on a 1 ml tuberculin syringe will be inserted into the anterior chamber and used to collect 0.1 ml of aqueous fluid from each eye. Aqueous PGE2 and Inflammatory cytokines will be measured
Locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States