Clinical Trial: Topical IL-1-Ra for Treatment of Corneal Neovascularization

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Reza Dana, MD

Current Primary Outcome:

• Incidence and Severity of Ocular Adverse Event [ Time Frame: 64 Weeks ]
  Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
• Extent of Neovascular Area (NA) [ Time Frame: 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.
• Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome: Changes in the extent of corneal NV at Week 6, 12, 24 and 64 by measurement of: Neovascular Area (NA) Vessel Caliber (VC) Invasion Area (IA) [ Time Frame: 64 Weeks ]

Current Secondary Outcome:

• Best Spectacle-Corrected Visual Acuity (BSCVA) [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome: Best Spectacle-Corrected Visual Acuity (BSCVA) at Week-6, 12, 24, 64 and central corneal thickness at Week-6, 12, 24, 64 [ Time Frame: 64 weeks ]

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: June 4, 2009
Date Started: April 2009
Date Completion:
Last Updated: May 5, 2017
Last Verified: May 2017