Corneal Neovascularization
Conditions
Brief summary
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.
Interventions
DRUGBevacizumab (Avastin)
Bevacizumab 10mg/mL 1 drop BID x 3 weeks
Sponsors
Massachusetts Eye and Ear Infirmary
Walter Reed Army Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* male or female, at least 18 years of age * clinically stable corneal neovascularization * superficial or deep corneal neovascularization that extends farther than 2mm from the limbus * 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. Clinical stability - all of the following criterial should be excluded before a corneal neovascularization can be regarded as clinically stable: * current or recent (\<3 months) episode of corneal and ocular surface infection (bacterial, viral, fungal, or acanthamoebal) * recent (\<3 months) ocular surgery, including cataract surgery, and/or laser of any type in the study eye * recent (\<6 months) full thickness or lamellar keratoplasty * recent (\<6 months) ocular surface reconstruction, limbal auto or allograft stem cell transplantation, or amniotic membrane transplantation * current or recent (\<3 months) use of contact lens or plan to use contact lens (excluding bandage contact lens) * current or recent (\<3 months) persistent corneal epithelial defect (of at leat 14 days duration) measuring more than 1mm2
Exclusion criteria
* current or recent (\<1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye * current or recent (\<3 months) intravitreal durg 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 \>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 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. * any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study. * any condition that precludes the patient's ability or an assisting family member's ability to apply the medication drops or to sustain five minutes of pressure on the lacrimal ducts after drop application. * concurrent enrollment in another clinical investigation medicinal product or device study is prohibited.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (Ocular and Systemic) | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Size and Extent of Corneal Neovascularization | 24 weeks | computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Ophthalmology Service at Walter Reed Army Medical Center, Washington DC from August 2007 to January 2011
Participants by arm
| Arm | Count |
|---|---|
| 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 | 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 | 52.3 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
Adverse Events (Ocular and Systemic)
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Avastin 1.0% | Adverse Events (Ocular and Systemic) | 0 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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Avastin 1.0% | Size and Extent of Corneal Neovascularization | 27.9 percentage change | Standard Deviation 9.2 |