Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study

Phase 1

Completed

• Conditions: Inflammation
• Interventions: Drug: Intravitreal Ketorolac

• Registration Number: NCT01164085
• Lead Sponsor: Vanderbilt University

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

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-30
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketorolac	Intravitreal Ketorolac	4mg intravitreal injection of ketorolac

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt Eye Institute; 🇺🇸 Nashville, Tennessee, United States