Back to resultsTopical IL-1-Ra for Treatment of Corneal Neovascularization
Primary Purpose
Corneal Neovascularization
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
IL-1Ra
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Neovascularization
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
Sites / Locations
- Massachusetts Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo first, then IL-1RA
IL-1RA first, then Placebo
Arm 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.
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
Outcomes
Primary Outcome Measures
Incidence and Severity of Ocular Adverse Event
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00915590
Brief Title
Topical IL-1-Ra for Treatment of Corneal Neovascularization
Official Title
Topical IL-1-Ra for Treatment of Corneal Neovascularization
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Reza Dana, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo first, then IL-1RA
Arm Type
Experimental
Arm 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.
Arm Title
IL-1RA first, then Placebo
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Custom eye drop eye three times a day in both eyes for a period of 6 weeks
Intervention Type
Drug
Intervention Name(s)
IL-1Ra
Other Intervention Name(s)
Kineret
Intervention Description
5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
Primary Outcome Measure Information:
Title
Incidence and Severity of Ocular Adverse Event
Description
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
Time Frame
64 Weeks
Title
Extent of Neovascular Area (NA)
Description
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
Title
Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels
Description
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
Title
Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels
Description
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 Outcome Measure Information:
Title
Best Spectacle-Corrected Visual Acuity (BSCVA)
Description
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
Title
Central Corneal Thickness
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Dana, MD, MPH, MSc
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Topical IL-1-Ra for Treatment of Corneal Neovascularization
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