Intravitreal Celecoxib for Chronic Uveitis

NCT02131012

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 15 years or younger Have active ocular infection Pregnancy Phakic subjects

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InflammationIntravitreal Celecoxib for Chronic Uveitis
NCT02131012
ALL GENDERS
15 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Intravitreal Celecoxib for Chronic Uveitis
Official Title  ICMJE Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study
Brief Summary 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Inflammation
Intervention  ICMJE Drug: Intravitreal Celecoxib
1-4 mg intravitreal celecoxib
Other Names:
  • Celebrex
  • NSAIDS
Study Arms  ICMJE Experimental: Celecoxib
1-4 mg intravitreal injection ofCelecoxib
Intervention: Drug: Intravitreal Celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 20, 2017)
4
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2014)
20
Actual Study Completion Date  ICMJE November 1, 2016
Actual Primary Completion Date November 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02131012
Other Study ID Numbers  ICMJE IND for Celecoxib
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen J. Kim, MD, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Vanderbilt University Medical Center
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP