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

This study has been completed.
Sponsor:
Collaborator:
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Michael J. Mines, MD, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00512876
First received: August 6, 2007
Last updated: July 3, 2013
Last verified: July 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Adverse Events (Ocular and Systemic) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Size and Extent of Corneal Neovascularization [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 6, 2007
Results First Received: May 15, 2013
Last Updated: July 3, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 20, 2014