Inflammation Clinical Trial
Official title:
Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study
Intraocular delivery of celecoxib will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.
Specific Aims I: Test the safety of intraocular injection of 1mg and 4mg celecoxib in
patients who have chronic inflammation or macular edema who are unable to tolerate
corticosteroids due to their side effects.
II: Test the efficacy of intraocular 1mg and 4mg celecoxib in treating inflammation or
structural complications of inflammation (macular edema) in patients who are unable to
tolerate corticosteroids due to their side effects.
After investigational new drug application and Vanderbilt Institutional Review Board
approval, celecoxib will be compounded by the Investigational Drug Service of the Vanderbilt
Medical Center and packaged in individual sterile single use syringes for intraocular
injection within 2 hours of preparation. Pharmaceutical grade celecoxib will be obtained
from the drug manufacturer (Pfizer) with certificate analysis and compounded in sterile
dimethyl sulfoxide following strict sterile technique.
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