search
Back to results

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

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravitreal Ketorolac
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Inflammation, Macular Edema

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketorolac

Arm Description

4mg intravitreal injection of ketorolac

Outcomes

Primary Outcome Measures

Safety
Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2010
Last Updated
December 30, 2013
Sponsor
Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT01164085
Brief Title
Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study
Acronym
INCITE
Official Title
Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Inflammation, Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
4mg intravitreal injection of ketorolac
Intervention Type
Drug
Intervention Name(s)
Intravitreal Ketorolac
Other Intervention Name(s)
ketorolace, tromethamine, preservative free
Intervention Description
4mg of intravitreal ketorolac
Primary Outcome Measure Information:
Title
Safety
Description
Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Kim, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Eye Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8808
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22491916
Citation
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. doi: 10.1001/archopthalmol.2011.2627. Erratum In: Arch Ophthalmol. 2012 Jun;130(6):742.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22491916
Description
Related Info

Learn more about this trial

Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study

We'll reach out to this number within 24 hrs