Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study

NCT ID: NCT01164085

Last Updated: 2013-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Inflammation

Keywords

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Inflammation Macular Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketorolac

4mg intravitreal injection of ketorolac

Group Type EXPERIMENTAL

Intravitreal Ketorolac

Intervention Type DRUG

4mg of intravitreal ketorolac

Interventions

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Intravitreal Ketorolac

4mg of intravitreal ketorolac

Intervention Type DRUG

Other Intervention Names

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ketorolace, tromethamine, preservative free

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Stephen J. Kim, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt Eye Institute

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22491916 (View on PubMed)

Related Links

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Other Identifiers

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091196

Identifier Type: -

Identifier Source: org_study_id