Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inflammation
Intervention: Intravitreal Ketorolac (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): Stephen J Kim, MD, Principal Investigator, Affiliation: Vanderbilt University
Summary
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.
Clinical Details
Official title: Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Vanderbilt Eye Institute, Nashville, Tennessee 37232-8808, United States
Additional Information
Starting date: December 2009
Last updated: December 30, 2013
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