Topical IL-1-Ra for Treatment of Corneal Neovascularization

Corneal Neovascularization Clinical Trial

Official title:

Topical IL-1-Ra for Treatment of Corneal Neovascularization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00915590
• Other study ID #: 09-03-017
• Secondary ID: Protocol #09-03-
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 4, 2009
• Last updated: May 5, 2017
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2017
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 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

Related Conditions & MeSH terms

• Corneal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• Placebo
Custom eye drop eye three times a day in both eyes for a period of 6 weeks
• IL-1Ra
5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Reza Dana, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of Ocular Adverse Event	Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.	64 Weeks
Primary	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.	64 weeks
Primary	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.	64 Weeks
Primary	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.	64 Weeks
Secondary	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.	64 weeks
Secondary	Central Corneal Thickness	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.	64 Weeks