NCT00915590 - Topical IL-1-Ra for Treatment of Corneal Neovascularization | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

10

Conditions

Corneal Neovascularization

Interventions

PlaceboDRUG

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

IL-1RaDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Incidence and Severity of Ocular Adverse Event

Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 64 Weeks

Secondary Outcomes

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.