Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
Primary Purpose
Lipid Keratopathy, Penetrating Keratoplasty, Herpetic Keratopathy
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Lipid Keratopathy focused on measuring corneal neovascularization, lipid keratopathy, penetrating keratopathy, bevacizumab, Avastin, subconjunctival injection
Eligibility Criteria
Inclusion Criteria:
- Significant unilateral or bilateral corneal neovascularization that extending over the limbus at least 2mm
- The underlying etiologies that caused corneal neovascularization included post penetrating keratoplasty (PKP), trauma, infectious or non-infectious corneal ulcer, post-keratoplasty, etc.
- Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25
- Post-PKP corneal neovascularization that had no associated lipid keratopathy, no corneal edema, or corneal irregularity. But the neovascularization was highly possible to cause graft rejection.
- The corneal neovascularization was refractory to other medical treatment
- The patient had received PKP or other corneal surgeries more than half a year ago and was not in the acute post-operation phase
- The patient had no active endopthalmitis, glaucoma with uncontrolled intraocular pressure, or vitreoretinal diseases
- The patient signed inform consent to have regular follow up and treatment
Exclusion Criteria:
- The neovascularization had clinical improvement three months before the first injection
- The lipid keratopathy had clinical improvement three months before the first injection
- The patient that suspected to have poor visual outcome or had already been light sense negative
- Glaucoma patient that had uncontrolled intraocular pressure
- Poor corneal epithelialization
- Post-PKP patient that had graft failure or rejection
- Patient that had systemic disease which was not suitable for bevacizumab use
- Pregnant patient
Sites / Locations
- Department of Ophthalmology, National Taiwan University Hospital,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
13 cases that accepted subconjunctival injection of bevacizumab
Outcomes
Primary Outcome Measures
Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity
Secondary Outcome Measures
major side effects
Full Information
NCT ID
NCT00681603
First Posted
May 19, 2008
Last Updated
May 20, 2008
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00681603
Brief Title
Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
Official Title
The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this human interventional study is to report the treatment outcome of subconjunctival injection of bevacizumab in patients with corneal neovascularization.
Material and methods: We enrolled 13 patients with unilateral or bilateral clinically significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival injection of bevacizumab once per month for at most 7 times was performed according to clinical response.
Main outcome measurements: resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Keratopathy, Penetrating Keratoplasty, Herpetic Keratopathy, Rosacea
Keywords
corneal neovascularization, lipid keratopathy, penetrating keratopathy, bevacizumab, Avastin, subconjunctival injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
13 cases that accepted subconjunctival injection of bevacizumab
Intervention Type
Drug
Intervention Name(s)
subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
Other Intervention Name(s)
bevacizumab ( Avastin )
Intervention Description
subconjunctival injection of bevacizumab ( 1.25 to 2.50mg) according to the clinical judgment. Once per months for three times then reevaluate the drug effect, if the response was adequate, stop the trial; if no improvement, another three month intervention would be performed.
Primary Outcome Measure Information:
Title
Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity
Time Frame
prospective
Secondary Outcome Measure Information:
Title
major side effects
Time Frame
prospective
10. Eligibility
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Significant unilateral or bilateral corneal neovascularization that extending over the limbus at least 2mm
The underlying etiologies that caused corneal neovascularization included post penetrating keratoplasty (PKP), trauma, infectious or non-infectious corneal ulcer, post-keratoplasty, etc.
Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25
Post-PKP corneal neovascularization that had no associated lipid keratopathy, no corneal edema, or corneal irregularity. But the neovascularization was highly possible to cause graft rejection.
The corneal neovascularization was refractory to other medical treatment
The patient had received PKP or other corneal surgeries more than half a year ago and was not in the acute post-operation phase
The patient had no active endopthalmitis, glaucoma with uncontrolled intraocular pressure, or vitreoretinal diseases
The patient signed inform consent to have regular follow up and treatment
Exclusion Criteria:
The neovascularization had clinical improvement three months before the first injection
The lipid keratopathy had clinical improvement three months before the first injection
The patient that suspected to have poor visual outcome or had already been light sense negative
Glaucoma patient that had uncontrolled intraocular pressure
Poor corneal epithelialization
Post-PKP patient that had graft failure or rejection
Patient that had systemic disease which was not suitable for bevacizumab use
Pregnant patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Li Chen
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, National Taiwan University Hospital,
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
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