Clinical trial NCT00915590: Topical IL-1-Ra for Treatment of Corneal Neovascularization
Official title: Topical IL-1-Ra for Treatment of Corneal Neovascularization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Corneal Neovascularization
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2009-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence and Severity of Ocular Adverse Event
timeFrame: 64 Weeks
measure: Extent of Neovascular Area (NA)
timeFrame: 64 weeks
measure: Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels
timeFrame: 64 Weeks
measure: Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels
timeFrame: 64 Weeks
Secondary outcomes:
measure: Best Spectacle-Corrected Visual Acuity (BSCVA)
timeFrame: 64 weeks
measure: Central Corneal Thickness
timeFrame: 64 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Reza Dana, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References: