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

NCT00512876 | Completed Results

• 1 other identifier: WRAMC WU# 07-23022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Neovascularization

Outcome Measures

Primary Outcomes (1)

• Adverse Events (Ocular and Systemic)

  24 weeks

Secondary Outcomes (1)

• Size and Extent of Corneal Neovascularization

  24 weeks

Interventions

Bevacizumab (Avastin) DRUG

Bevacizumab 10mg/mL 1 drop BID x 3 weeks

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead
• Massachusetts Eye and Ear Infirmary: collaborator

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Corneal Neovascularization

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Principal Investigator
• Organization: U.S. Army Warfighter Refractive Surgery Research Center

rose.sia@us.army.mil

571-231-1600

Study Officials

• Michael J Mines, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, Ophthalmology

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 22, 2013
• Results First Posted: July 3, 2013

Record last verified: 2013-07

Locations

US (1)