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

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.

Study Overview

• Status: Completed
• Conditions: Corneal Neovascularization
• Intervention / Treatment: Drug: Bevacizumab (Avastin)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events (Ocular and Systemic)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Collaborators and Investigators

• Sponsor: Walter Reed Army Medical Center
• Collaborators: Massachusetts Eye and Ear Infirmary

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: August 6, 2007
• First Submitted That Met QC Criteria: August 6, 2007
• First Posted (ESTIMATE): August 8, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): July 22, 2013
• Last Update Submitted That Met QC Criteria: July 3, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Corneal Diseases; Metaplasia; Neovascularization, Pathologic; Corneal Neovascularization; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: WRAMC WU# 07-23022