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

Corneal Neovascularization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512876
• Other study ID #: WRAMC WU# 07-23022
• Status: Completed
• Phase: N/A
• First received: August 6, 2007
• Last updated: July 3, 2013
• Start date: August 2007
• Est. completion date: January 2011

Study information

• Verified date: July 2013
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• Bevacizumab (Avastin)
Bevacizumab 10mg/mL 1 drop BID x 3 weeks

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center	Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (Ocular and Systemic)		24 weeks	Yes
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.	24 weeks	No