Topical IL-1-Ra for Treatment of Corneal Neovascularization

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to determine the effectiveness and safety of Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.

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Detailed Description

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Normally avascular, under many pathologic conditions, vessels may invade the cornea from the limbal vascular plexus. Infection, inflammation, ischemia, degeneration, or trauma, and the loss of the limbal stem cell barrier can cause corneal neovascularization. Growth of new vessels may result in corneal scarring, edema, lipid deposition, and inflammation that may alter visual acuity and is a leading cause of monocular visual impairment and blindness. Additionally, it results in the loss of immune response across the cornea, thereby worsening the prognosis of a subsequent penetrating keratoplasty (PK). Growth of new blood and lymphatic vessels from preexisting vessels are mediated by members of the vascular endothelial growth factor (VEGF) family. This study is designed to investigate whether Interleukin-1-Receptor Antagonist is a drug that is both safe and effective in blocking VEGF pathways, stopping new growth, and reducing old vessel growth.

Conditions

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Corneal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo first, then IL-1RA

It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Custom eye drop eye three times a day in both eyes for a period of 6 weeks

IL-1Ra

Intervention Type DRUG

5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

IL-1RA first, then Placebo

It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Custom eye drop eye three times a day in both eyes for a period of 6 weeks

IL-1Ra

Intervention Type DRUG

5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Interventions

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Placebo

Custom eye drop eye three times a day in both eyes for a period of 6 weeks

Intervention Type DRUG

IL-1Ra

5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Intervention Type DRUG

Other Intervention Names

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Kineret

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Patients with superficial or deep corneal NV that extends farther than 1 mm from the limbus

Exclusion Criteria

* Corneal or ocular surface infection within 30 days prior to study entry• Ocular or periocular malignancy
* Contact lens (excluding bandage contact lens) use within 2 weeks prior to study entry
* Persistent epithelial defect (\>1mm and ≥14 days duration) within 2 weeks prior to study entry
* Intravitreal or periocular steroids within 2 weeks prior to study entry
* Change in dose/frequency of topical steroids and/or NSAIDs within 2 weeks prior to study entry
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using contraception
* Signs of current infection, including fever and current treatment with antibiotics
* Participation in another simultaneous medical investigation or trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No