NCT01164085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

April 19, 2010

Last Update Submit

December 30, 2013

Conditions

Inflammation

Keywords

InflammationMacular Edema

Outcome Measures

Primary Outcomes (1)

  • Safety

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

    90 days

Study Arms (1)

Ketorolac

EXPERIMENTAL

4mg intravitreal injection of ketorolac

Drug: Intravitreal Ketorolac

Interventions

Intravitreal KetorolacDRUG

4mg of intravitreal ketorolac

Also known as: ketorolace, tromethamine, preservative free
Ketorolac

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • years or younger
  • Have active ocular infection
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Eye Institute

Nashville, Tennessee, 37232-8808, United States

Location

Related Publications (1)

  • 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.

    PMID: 22491916RESULT

Related Links

MeSH Terms

Conditions

InflammationMacular Edema

Interventions

Tromethamine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMacular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Propylene GlycolsGlycolsAlcoholsOrganic Chemicals

Study Officials

  • Stephen J Kim, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2010

First Posted

July 16, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

US(1)