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

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ClinicalTrials.gov Identifier: NCT00512876
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : July 3, 2013
Last Update Posted : July 22, 2013
Sponsor:
Collaborator:
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Michael J. Mines, MD, Walter Reed Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Corneal Neovascularization Drug: Bevacizumab (Avastin) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Study Start Date : August 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources


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


Primary Outcome Measures :
  1. Adverse Events (Ocular and Systemic) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Size and Extent of Corneal Neovascularization [ Time Frame: 24 weeks ]
    computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline.



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512876


Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Michael J Mines, MD Walter Reed Army Medical Center

Responsible Party: Michael J. Mines, MD, Research Director, Ophthalmology, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00512876     History of Changes
Other Study ID Numbers: WRAMC WU# 07-23022
First Posted: August 8, 2007    Key Record Dates
Results First Posted: July 3, 2013
Last Update Posted: July 22, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Neovascularization, Pathologic
Corneal Neovascularization
Metaplasia
Pathologic Processes
Corneal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents