The Role of Prostaglandins in the Progression of Diabetic Retinopathy
Status:
Withdrawn
Trial end date:
2016-10-19
Target enrollment:
Participant gender:
Summary
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