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The Role of Prostaglandins in the Progression of Diabetic Retinopathy and the Therapeutic Efficacy of Topical Ketorolac (Acuvail)


N/A
18 Years
90 Years
Open (Enrolling)
Both
Inflammation

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Trial Information

The Role of Prostaglandins in the Progression of Diabetic Retinopathy and the Therapeutic Efficacy of Topical Ketorolac (Acuvail)


Patients who require vitrectomy for any indication and those meeting the inclusion/exclusion
criteria will be included. Patients will be consented to participate in the study and for
surgery.

Nondiabetic patients will be included in one of two groups. Twenty will receive topical
ketorolac (Acuvail®) preoperatively for 3 days and then samples will be taken at the time of
surgery. Twenty other patients will serve as controls for intraocular prostaglandin and
cytokine levels (to be compared to diabetic patients). This group will not receive
preoperative ketorolac (Acuvail®).

Diabetic patients will be included in one of two groups. Twenty patients will have
intraocular prostaglandin and cytokine levels measured. Twenty other patients will be in the
interventional group to determine if topical ketorolac (Acuvail®) can successfully lower
intraocular prostaglandin and inflammatory cytokine levels.

In all cases, patients are undergoing vitreoretinal surgery as the surgical treatment of
choice for their condition. For this study, undiluted samples will be drawn from the
vitreous cavity and anterior chamber at the beginning of the vitrectomy. These samples will
be stored, analyzed and frozen.

Samples will be tested for prostaglandin levels, in addition to other inflammatory
cytokines, and ketorolac levels.

Three days of Acuvail® given four times per day was chosen, as previous studies have shown
that one dose of ketorolac 0.4% achieves a peak aqueous concentration of 57.5 ng/mL,1 and
that 12 doses over two days achieves an aqueous concentration of 1079 ng/mL.2 Both values
are well above the IC50 for COX-1 (5.3 to 7.5 ng/mL) and COX-2 (33.9-45.2 ng/mL). The upper
end of this dosing spectrum was chosen, as more doses and a longer duration of therapy is
likely required to achieve sufficient vitreous levels to inhibit COX-1 and COX-2. This
dosing regimen was also used in another clinical study that assessed ketorolac levels and
prostaglandin levels in the vitreous cavity after topical administration four times a day
for three days preoperatively.3


Inclusion Criteria:



1. Adult patients aged 18 years or older who present for vitrectomy surgery for any
indication.

2. Diabetic and non-diabetic patients will be included.

Exclusion criteria:

1. Patients under the age of 18 years of age.

2. Pregnant women.

3. Patients with a history of vitrectomy surgery.

4. Current topical, periocular, intraocular or systemic corticosteroid use

5. Co-existent macular, retinovascular or ocular inflammatory disease (age-related
macular degeneration, retinal venous occlusive disease, uveitis, etc.)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Vitreous and anterior chamber levels of prostaglandins, other cytokines, and Acuvail

Outcome Description:

Vitreous and anterior chamber levels of prostaglandins, other cytokines, and Acuvail

Outcome Time Frame:

3 days

Safety Issue:

No

Principal Investigator

Stephen J Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt Eye Institute

Authority:

United States: Institutional Review Board

Study ID:

12022

NCT ID:

NCT01609881

Start Date:

March 2012

Completion Date:

March 2013

Related Keywords:

  • Inflammation
  • Inflammation
  • Diabetic Retinopathy
  • Inflammation
  • Retinal Diseases

Name

Location

Vanderbilt Eye InstituteNashville, Tennessee  37232-8808