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: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2010
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.
- Drug: Intravitreal Ketorolac
- 4mg of intravitreal ketorolac
Arms, Groups and Cohorts
- Experimental: Ketorolac
- 4mg intravitreal injection of ketorolac
Clinical Trial Outcome Measures
- 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
- 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
- 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.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.