Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study

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.

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Key information

Conditions

Inflammation Eye Diseases Macular Degeneration Macular Edema Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt Eye Institute

Nashville, Tennessee, 37232-8808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal Ketorolac

Drug

4mg of intravitreal ketorolac

Other names: ketorolace, tromethamine, preservative free

Primary outcomes

Safety

Time frame: 90 days

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Acronym: INCITE

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 16, 2010
Registry last updated: Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed