Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study (INCITE)
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|ClinicalTrials.gov Identifier: NCT01164085|
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : December 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Drug: Intravitreal Ketorolac||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study|
|Study Start Date :||December 2009|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
4mg intravitreal injection of ketorolac
Drug: Intravitreal Ketorolac
4mg of intravitreal ketorolac
Other Name: ketorolace, tromethamine, preservative free
- Safety [ Time Frame: 90 days ]Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164085
|United States, Tennessee|
|Vanderbilt Eye Institute|
|Nashville, Tennessee, United States, 37232-8808|
|Principal Investigator:||Stephen J Kim, MD||Vanderbilt University|