Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study (INCITE)

Vanderbilt University

Status and phase: Completed; Phase 1

Conditions: Inflammation

Treatments: Drug: Intravitreal Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT01164085

091196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ketorolac

Experimental group

Description:

4mg intravitreal injection of ketorolac

Treatment:

Drug: Intravitreal Ketorolac