Clinical trial NCT00512876: Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Official title: Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Neovascularization
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
Collaborators: name: Massachusetts Eye and Ear Infirmary
First posted: 2007-08-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events (Ocular and Systemic)
timeFrame: 24 weeks
Secondary outcomes:
measure: Size and Extent of Corneal Neovascularization
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: Michael J Mines, MD
role: PRINCIPAL_INVESTIGATOR
References: