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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol #09-03-017 | Other Identifier | Massachusetts Eye and Ear Infirmary |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo first, then IL-1RA | Experimental | 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. |
|
| IL-1RA first, then Placebo | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Custom eye drop eye three times a day in both eyes for a period of 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Dana, MD, MPH, MSc | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
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This is a single site, randomized, double masked, crossover, phase I/II study of topical IL-1Ra (5.0%) in subjects with corneal neovascularization.
Patients in this study were recruited from Mass. Eye and Ear Infirmary from May 2009 - February 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then IL-1Ra | 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra. IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks |
| FG001 | IL-1Ra First, Then Placebo | 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo First, Then IL-1Ra | 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra. IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence and Severity of Ocular Adverse Event | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing. | Posted | Number | participants | 64 Weeks |
|
Adverse events were collected over a 9 month period (May 2009 - February 2010).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itchy Eyes | Eye disorders | Non-systematic Assessment |
Enrollment goal for this study was set at 20 participants (10 for each treatment arm). After an interim analysis, the Principal Investigator decided to terminate the study and stop enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reza Dana, MD, MPH, MSc | Massachusetts Eye and Ear Infirmary | 617-573-3313 | Cornea_Research@meei.harvard.edu |
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| ID | Term |
|---|---|
| D016510 | Corneal Neovascularization |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| IL-1Ra | Drug | 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks |
|
|
| 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 |
| BG001 |
| IL-1Ra First, Then Placebo |
10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | 64 Weeks |
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | IL-1Ra | IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks | 0 | 10 | 1 | 10 |
| EG002 | Off Treatment | Off treatment | 0 | 10 | 2 | 10 |
| Eye Redness | Eye disorders | Non-systematic Assessment |
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| Eye Pain | Eye disorders | Non-systematic Assessment |
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| Diminished Vision | Eye disorders | Non-systematic Assessment |
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| Ocular Herpes Flare-up | Eye disorders | Non-systematic Assessment |
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| Gall Bladder Hospitalization | Gastrointestinal disorders | Systematic Assessment |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 | Proteins |
| D001685 | Biological Factors |