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

Primary Purpose

Corneal Neovascularization

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab (Avastin)
Sponsored by
Walter Reed Army Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Neovascularization

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Walter Reed Army Medical Center

Outcomes

Primary Outcome Measures

Adverse Events (Ocular and Systemic)

Secondary Outcome Measures

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.

Full Information

First Posted
August 6, 2007
Last Updated
July 3, 2013
Sponsor
Walter Reed Army Medical Center
Collaborators
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT00512876
Brief Title
Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Official Title
Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed Army Medical Center
Collaborators
Massachusetts Eye and Ear Infirmary

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bevacizumab (Avastin)
Intervention Description
Bevacizumab 10mg/mL 1 drop BID x 3 weeks
Primary Outcome Measure Information:
Title
Adverse Events (Ocular and Systemic)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Size and Extent of Corneal Neovascularization
Description
computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Mines, MD
Organizational Affiliation
Walter Reed Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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