A Phase 1 interventional study of Intravitreal Celecoxib in Inflammation, sponsored by Vanderbilt University. Terminated. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Vanderbilt University · Phase 1, Interventional, and Treatment
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.
335 studies on the registry are indexed under Uveitis; 37 are open to participants now.
This study's enrollment of 4 is below the median of 30 across 208 interventional studies indexed under Uveitis.
Browse Uveitis studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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Exclusion Criteria:
1-4 mg intravitreal injection ofCelecoxib
Drug: Intravitreal Celecoxib
1-4 mg intravitreal celecoxib
Also known as: Celebrex, NSAIDS
Safety
Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events
Time frame: 12 weeks
Efficacy
Participant will receive the intravitreal injection of celecoxib day 1 and be followed for efficacy. The efficacy will be determined from the ophthalmic exams and aqueous samples
Time frame: 12 weeks
No study locations are listed for this record.
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt University