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The purpose of this study is to determine whether local injection of bevacizumab might halt and or cause regression of pterygium growth. This may enable earlier treatment and prevention of pterygium growth into the patient's line of sight thereby limiting the need for surgery and improving quality of life for patients with pterygia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | Bevacizumab injection: 0.1ml, 6 monthly doses plus baseline and 1 week post baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local injection of bevacizumab | Drug | Upon enrollment into the study: - initial injection of bevacizumab, a 1 week post-injection visit,and monthly visits thereafter for a total of 6 months. At the 1-month and 3-month visit post-injection visit, an additional bevacizumab injection will be offered if pterygium regression has not occurred. All injections of bevacizumab will consist of injecting 0.1mL of a 2.5mg/0.1mL concentration of bevacizumab into the head of the pterygium. |
| Measure | Description | Time Frame |
|---|---|---|
| The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection. | Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Having Surgical Removal of Pterygium. | The number of patients having surgical removal of pterygium within 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyler A Hall, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Callahan Eye Foundation Hospital | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections. |
| 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 | The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection. | Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression. | All subjects enrolled were analzyed. | Posted | Mean | Standard Deviation | area in millimeters squared | Baseline and 3 months |
|
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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 | Bevacizumab | The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulling at site of injection of avastin | Eye disorders | Non-systematic Assessment |
Initially we aimed for 10 to 15 subjects but only enrolled 5 subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tyler Hall, M.D. | University of Alabama at Birmingham | 205-325-8310 | tandrewhall@yahoo.com |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Number of Patients Having Surgical Removal of Pterygium. | The number of patients having surgical removal of pterygium within 12 months. | All subjects enrolled were analzyed. | Posted | Number | Participants | 12 months |
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| 0 |
| 5 |
| 4 |
| 5 |
| Subconjunctival hemorrhage at injection site | Eye disorders | Systematic Assessment |
|
| Ocular Irritation | Eye disorders | Non-systematic Assessment | Patient complained of irritation at site of injection which resolved. |
|
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