Topical IL-1-Ra for Treatment of Corneal Neovascularization

Phase 1

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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 health

Exclusion 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

Arm && Interventions

Group	Intervention	Description
Placebo first, then IL-1RA	Placebo	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.
IL-1RA first, then Placebo	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
IL-1RA first, then Placebo	IL-1Ra	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
Placebo first, then IL-1RA	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.

Primary Outcome Measures

Name	Time	Method
Extent of Neovascular Area (NA)	64 weeks	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.
Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels	64 Weeks	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.
Incidence and Severity of Ocular Adverse Event	64 Weeks	Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels	64 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Best Spectacle-Corrected Visual Acuity (BSCVA)	64 weeks	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.
Central Corneal Thickness	64 Weeks	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.