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Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study (INCITE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01164085
First received: April 19, 2010
Last updated: July 15, 2010
Last verified: July 2010
History of Changes
  Purpose

Intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.


Condition Intervention Phase
Inflammation
 Drug: Intravitreal Ketorolac
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.


Estimated Enrollment: 20
Study Start Date: December 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketorolac
4mg intravitreal injection of ketorolac
 Drug: Intravitreal Ketorolac
4mg of intravitreal ketorolac
Other Name: ketorolace, tromethamine, preservative free

Detailed Description:

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.

Specific Aims

  1. 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.
  2. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult volunteers
  • Chronic intractable uveitis or chronic complications of uveitis (macular edema)despite maximal medical treatment
  • Unable to tolerate corticosteroids due to side effects

Exclusion Criteria:

  • 18 years or younger
  • Have active ocular infection
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164085

Locations
United States, Tennessee
Vanderbilt Eye Institute Recruiting
Nashville, Tennessee, United States, 37232-8808
Contact: Sandy A Owings     615-936-1474     sandy.owings@vanderbilt.edu    
Contact: Christine Franklin     615-936-1639     christine.franklin@vanderbilt.edu    
Principal Investigator: Stephen J Kim, MD            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Stephen J Kim, MD Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stephen Kim, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01164085     History of Changes
Other Study ID Numbers: 091196
Study First Received: April 19, 2010
Last Updated: July 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Inflammation
Macular Edema

Additional relevant MeSH terms:
Inflammation
Uveitis
Pathologic Processes
Uveal Diseases
Eye Diseases
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013