Inflammation
Conditions
Keywords
Inflammation, Macular Edema
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.
Interventions
DRUGIntravitreal Ketorolac
4mg of intravitreal ketorolac
Sponsors
Vanderbilt University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 90 days | Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity. |
Countries
United States
Outcome results
None listed