Intravitreal Celecoxib for Chronic Uveitis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects
Exclusion criteria
- 15 years or younger Have active ocular infection Pregnancy Phakic subjects
Trial design
Primary purpose
Allocation
Interventional model
Masking
4 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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