INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

November 9, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Diabetic Retinopathy
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

Trial Locations (1)

37232

Vanderbilt University Medical Center, Nashville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

collaborator

National Eye Institute (NEI)

NIH

lead

Stephen J. Kim, MD

OTHER