Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study (INCITE)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study|
- Safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.
|Study Start Date:||December 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
4mg intravitreal injection of ketorolac
Drug: Intravitreal Ketorolac
4mg of intravitreal ketorolac
Other Name: ketorolace, tromethamine, preservative free
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.
- 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.
- 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.
|United States, Tennessee|
|Vanderbilt Eye Institute|
|Nashville, Tennessee, United States, 37232-8808|
|Principal Investigator:||Stephen J Kim, MD||Vanderbilt University|