Overview

Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Walter Reed Army Medical Center
Collaborator:
Massachusetts Eye and Ear Infirmary
Treatments:
Bevacizumab
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.