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ACTIVE NOT RECRUITING
NCT04505566
PHASE1

INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study

Sponsor: Stephen J. Kim, MD

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

OTHER

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