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Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation

Intervention: Intravitreal Ketorolac (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Stephen J Kim, MD, Principal Investigator, Affiliation: Vanderbilt University

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.

Clinical Details

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

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

Primary outcome: Safety

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.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Vanderbilt Eye Institute, Nashville, Tennessee 37232-8808, United States
Additional Information

Starting date: December 2009
Last updated: December 30, 2013

Page last updated: August 23, 2015

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