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Completed NCT04505566

INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study

Conditions: Diabetic Retinopathy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 164
Sponsor: Stephen J. Kim, MD

Location: Vanderbilt University Medical Center Nashville Tennessee

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.

Eligibility Criteria

Inclusion Criteria: * Aim 1 Diabetic Arm Inclusion Criteria: Adult patients age 18 years or greater with type II diabetes. * Aim 1 Nondiabetic Control Arm Inclusion Criteria: age-matched patients without diabetes who are undergoing unilateral vitrectomy surgery for non-inflammatory conditions such as epiretinal membrane or macular hole. * Aim 2 Inclusion Criteria: Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and HbA1c ≥ 8. Exclusion Criteria: * Aim 1 Diabetic Arm Exclusion Criteria: Patients with a history of previous vitrectomy in either eye; prior intravitreal injection within 3 months; co-existent macular, retinovascular, or inflammatory disease; history of ocular trauma; aphakia; presence of an anterior chamber intraocular lens; current use of prescription systemic NSAIDs or regular use of nonprescription NSAIDs including aspirin (defined as 4 days or more a week for at least 2 weeks a month); blood pressure \> 180/110 mmHg; risk for corneal melting; and inability to comply with follow-up. * Aim 1 Nondiabetic Control Arm Exclusion Criteria: Patients who are unable to comply with testing and follow-up. * Aim 2 Exclusion Criteria: Patients with a history of previous vitrectomy in either eye; prior intravitreal injection within 3 months; co-existent macular, retinovascular, or inflammatory disease; history of ocular trauma; aphakia; presence of an anterior chamber intraocular lens; current use of prescription systemic NSAIDs or regular use of nonprescription NSAIDs including aspirin (defined as 4 days or more a week for at least 2 weeks a month); blood pressure \> 180/110 mmHg; risk for corneal melting; and inability to comply with follow-up.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04505566). StuddyBuddy aggregates publicly available trial information.