Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study

Overview

Intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.

Full Title of Study: “Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

Detailed Description

A Phase I safety study of intravitreal ketorolac in patients with chronic inflammation and complications due to inflammation who have either failed medical therapy or who cannot tolerate corticosteroids due to side effects.

Specific Aims

1. Test the safety of intraocular injection of 4mg of ketorolac in patients who have intractable uveitis or complications of uveitis such as chronic macular edema who are unable to tolerate corticosteroids due to their side effects.

2. Test the efficacy of intraocular 4m ketorolac of treating inflammation or structural complications of inflammation in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.

Interventions

  • Drug: Intravitreal Ketorolac
    • 4mg of intravitreal ketorolac

Arms, Groups and Cohorts

  • Experimental: Ketorolac
    • 4mg intravitreal injection of ketorolac

Clinical Trial Outcome Measures

Primary Measures

  • Safety
    • Time Frame: 90 days
    • Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult volunteers
  • Chronic intractable uveitis or chronic complications of uveitis (macular edema)despite maximal medical treatment
  • Unable to tolerate corticosteroids due to side effects

Exclusion Criteria

  • 18 years or younger
  • Have active ocular infection
  • Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephen J. Kim, MD, Principal Investigator – Vanderbilt University
  • Overall Official(s)
    • Stephen J Kim, MD, Principal Investigator, Vanderbilt University

Citations Reporting on Results

Kim SJ, Doherty TJ, Cherney EF. Intravitreal ketorolac for chronic uveitis and macular edema: a pilot study. Arch Ophthalmol. 2012 Apr;130(4):456-60. doi: 10.1001/archopthalmol.2011.2627. Erratum in: Arch Ophthalmol. 2012 Jun;130(6):742.

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