Topical IL-1-Ra for Treatment of Corneal Neovascularization

Study Overview
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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.

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.

Official Title
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Topical IL-1-Ra for Treatment of Corneal Neovascularization

Conditions
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Corneal Neovascularization

Intervention / Treatment
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* Drug: Placebo
* Drug: IL-1Ra


Participation Criteria
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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 Patients are in generally good stable overall healthExclusion Criteria: • Has received treatment with anti-VEGF agents (topical, intraocular or systemic) within 30 days of study entry 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo first, then IL-1RA<br>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. | Drug: Placebo<br>* Custom eye drop eye three times a day in both eyes for a period of 6 weeks<br>Drug: IL-1Ra<br>* 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks<br>* Other names: Kineret;|
| Experimental: IL-1RA first, then Placebo<br>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 | Drug: Placebo<br>* Custom eye drop eye three times a day in both eyes for a period of 6 weeks<br>Drug: IL-1Ra<br>* 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks<br>* Other names: Kineret;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and Severity of Ocular Adverse Event | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing. | 64 Weeks | 
| Extent of Neovascular Area (NA) | The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis. | 64 weeks | 
| Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels | The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis. | 64 Weeks | 
| Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels | The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis. | 64 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Spectacle-Corrected Visual Acuity (BSCVA) | The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis. | 64 weeks | 
| Central Corneal Thickness | The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis. | 64 Weeks |