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NCT01164085 Clinical Trial

Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study

Inflammation Clinical Trial

— INCITE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01164085
Other study ID # 091196
Secondary ID
Status Completed
Phase Phase 1
First received April 19, 2010
Last updated December 30, 2013
Start date December 2009
Est. completion date December 2010

Study information
Verified date December 2013
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Intravitreal Ketorolac
4mg of intravitreal ketorolac

Locations
Country Name City State
United States Vanderbilt Eye Institute Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: Arch Ophthalmol. 2012 Jun;130(6):742. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity. 90 days Yes
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