The Role of Prostaglandins in the Progression of Diabetic Retinopathy

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Inflammation

In brief

Objective of the research study: 1. To measure anterior chamber and vitreous ketorolac (Acuvail®) concentrations after topical administration in patients undergoing routine vitrectomy to determine the ability of the medication to penetrate into the anterior chamber and vitreous cavity, and to compare these levels to the IC50 for the cyclooxygenase-1 and -2 enzymes (COX-1 and COX-2) 2. To measure vitreous concentrations of prostaglandin subtypes (PGE, PGD, PGF) and other inflammatory mediators (Interleukin-1β \[IL-1β\], IL-6, IL-8, tumor necrosis factor \[TNF\]-α, VEGF) in both diabetic and nondiabetic patients undergoing vitrectomy 3. To determine if topical ketorolac (Acuvail®) can penetrate the anterior chamber and vitreous cavity sufficiently to decrease levels of intraocular inflammatory mediators that have been shown to be elevated in diabetic patients 4. To serve as a precursor to a 5-year longitudinal clinical trial to determine if chronically administered topical ketorolac (Acuvail®) can prevent, delay or slow diabetic retinopathy. Research hypothesis 1. Ketorolac (Acuvail®) will penetrate the anterior chamber and vitreous cavity sufficiently to achieve levels above the IC50 for COX-1 and COX-2 2. Prostaglandin and other inflammatory mediator levels in the anterior chamber and vitreous cavity will be significantly higher among diabetic patients than nondiabetic controls 3. Acuvail® can significantly lower anterior chamber and vitreous cavity levels of prostaglandins and other inflammatory mediators in diabetic patients

Key facts

Study ID

NCT01609881

Run by

Vanderbilt University

People needed

0

Starts

2012-03-01

Expected to finish

2016-10-19

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients aged 18 years or older who present for vitrectomy surgery for any indication.
• Diabetic and non-diabetic patients will be included.

You may not qualify if…

• Patients under the age of 18 years of age.
• Pregnant women.
• Patients with a history of vitrectomy surgery.
• Current topical, periocular, intraocular or systemic corticosteroid use
• Co-existent macular, retinovascular or ocular inflammatory disease (age-related macular degeneration, retinal venous occlusive disease, uveitis, etc.)

Where it is running

• Vanderbilt Eye Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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