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

Tracking Information

First Received Date ^ICMJE

April 19, 2010

Last Updated Date

July 15, 2010

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01164085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study

Official Title ^ICMJE

Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study

Brief Summary

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.

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

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.
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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Inflammation

Intervention ^ICMJE

Drug: Intravitreal Ketorolac

4mg of intravitreal ketorolac

Other Name: ketorolace, tromethamine, preservative free

Study Arm (s)

Experimental: Ketorolac

4mg intravitreal injection of ketorolac

Intervention: Drug: Intravitreal Ketorolac

Publications *

Kim SJ, Doherty TJ, Cherney EF. Intravitreal ketorolac for chronic uveitis and macular edema: a pilot study. Arch Ophthalmol. 2012 Apr;130(4):456-60.

* 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01164085

Other Study ID Numbers ^ICMJE

091196

Has Data Monitoring Committee

Responsible Party

Stephen Kim, MD, Vanderbilt University Medical Center

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stephen J Kim, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

July 2010

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

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