Pterygium
Conditions
Brief summary
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.
Interventions
DRUGlocal injection of bevacizumab
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 19 years of age and older * Diagnosis of pterygia * healthy enough to make scheduled follow-up visits
Exclusion criteria
* Women of childbearing potential and males who plan to father a child during their participation in the study will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection. | Baseline and 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Having Surgical Removal of Pterygium. | 12 months | The number of patients having surgical removal of pterygium within 12 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Bevacizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 51.5 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: Baseline and 3 months
Population: All subjects enrolled were analzyed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab | The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection. | 5.75 area in millimeters squared | Standard Deviation 2.91 |
p-value: 0.83t-test, 2 sided
Secondary
Number of Patients Having Surgical Removal of Pterygium.
The number of patients having surgical removal of pterygium within 12 months.
Time frame: 12 months
Population: All subjects enrolled were analzyed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Number of Patients Having Surgical Removal of Pterygium. | 0 Participants |