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| Name | Class |
|---|---|
| Massachusetts Eye and Ear Infirmary | OTHER |
Purpose: To determine the efficacy and safety of one commonly used VEGF inhibitor, bevacizumab (Avastin, Genentech), as a topical agent for the treatment of corneal neovascularization.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab (Avastin) | Drug | Bevacizumab 10mg/mL 1 drop BID x 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (Ocular and Systemic) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Size and Extent of Corneal Neovascularization | computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline. | 24 weeks |
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Inclusion Criteria:
Clinical stability - all of the following criterial should be excluded before a corneal neovascularization can be regarded as clinically stable:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Mines, MD | Walter Reed Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
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Participants were recruited from the Ophthalmology Service at Walter Reed Army Medical Center, Washington DC from August 2007 to January 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Avastin 1.0% | Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Avastin 1.0% | Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 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 | Adverse Events (Ocular and Systemic) | Posted | Number | participants | 24 weeks |
|
|
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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 | Topical Avastin 1.0% | Each participant received topical Avastin to be applied to the affected eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | U.S. Army Warfighter Refractive Surgery Research Center | 571-231-1600 | rose.sia@us.army.mil |
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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 |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Size and Extent of Corneal Neovascularization | computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline. | Posted | Mean | Standard Deviation | percentage change | 24 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
All materials that reflects the WRAMC affiliation must be approved and properly cleared before the material is submitted for public dissemination and publication. All publications whereby WRAMC is cited in the bylines will state on the cover page the following sample disclaimer: "The views expressed in this [article, book chapter, speech, presentation, etc.] are those of the author(s) and do not reflect the official policy of the Department of Army, Department of Defense, or U.S. Government."
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |