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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512876
First Posted: August 8, 2007
Last Update Posted: July 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Michael J. Mines, MD, Walter Reed Army Medical Center
  Purpose
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 Intervention
Corneal Neovascularization Drug: Bevacizumab (Avastin)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Michael J. Mines, MD, Walter Reed Army Medical Center:

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

Secondary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: August 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab (Avastin)
    Bevacizumab 10mg/mL 1 drop BID x 3 weeks
  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

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 Submitted: August 6, 2007
First Posted: August 8, 2007
Results First Submitted: May 15, 2013
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