Topical IL-1-Ra for Treatment of Corneal Neovascularization

Reza Dana, MD

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Corneal Neovascularization

Treatments: Drug: IL-1Ra; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00915590

Protocol #09-03-017 (Other Identifier)

09-03-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Placebo first, then IL-1RA

Experimental group

Description:

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.

Treatment:

Drug: IL-1Ra

Drug: Placebo

IL-1RA first, then Placebo

Experimental group

Description:

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

Treatment:

Drug: IL-1Ra

Drug: Placebo