Corneal Neovascularization
Conditions
Brief summary
The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization.
Detailed description
Primary outcomes measures included neovascular area (NA), defined as the area of the corneal vessels themselves; vessel caliber (VC), defined as the mean diameter of the corneal vessels; and invasion area (IA), defined as the fraction of the total cornea into which the vessels extend. The occurrence of ocular and systemic adverse events was closely monitored throughout the course of the study.
Interventions
DRUGTopical Avastin 1%
Avastin (bevacizumab) 1%
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, at least 18 years of age * Clinical stable corneal neovascularization (as defined above) * Ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits. * All female patients of childbearing potential will be excluded. A female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.
Exclusion criteria
* Current or recent (≤ 1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye * Current or recent (≤ 3 months) intravitreal drug injection to the study eye; recent (≤ 1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents * Uncontrolled hypertension defined as systolic blood pressure of ≥ 150 mmHg or diastolic blood pressure of ≥ 90 mmHg; history of a thromboembolic event, including myocardial infarction or cerebral vascular accident * Patients age 75 or older; history of renal abnormalities * Recent (≤ 3 months ) or planned surgery * History of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin, or similar anticoagulant agent) * All female patients of childbearing potential (a female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries) * Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study. | Six Months | The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured. |
| Ocular and Systemic Safety | All study visits | The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Cornea Service at Massachusetts Eye and Ear Infirmary from February 2007 through October 2010.
Pre-assignment details
Only patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.
Participants by arm
| Arm | Count |
|---|---|
| Topical Avastin 1.0% Each patient will receive topical Avastin in one eye. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Topical Avastin 1.0% |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 52.5 years STANDARD_DEVIATION 3.3 |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Ocular and Systemic Safety
The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.
Time frame: All study visits
Population: Participants treated with investigational medication were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Avastin 1.0% | Ocular and Systemic Safety | 0 participants |
Primary
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.
The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.
Time frame: Six Months
Population: Participants who received investigational treatment were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Avastin 1.0% | The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study. | 27.9 percent change since baseline | Standard Deviation 9.2 |