Back to resultsBevacizumab for the Treatment of Corneal Neovascularization
Primary Purpose
Corneal Neovascularization
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Neovascularization focused on measuring Corneal neovascularization, bevacizumab
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), ocular surface reconstruction , trauma, infectious or non-infectious corneal ulcer.
- Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25.
- Post-PSP or ocular surface reconstruction 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 mort than half a year ago and was not in the acute post-operation phase.
- The patient had no active endophthalmitis, 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.
- Patient that had systemic disease which was not suitable for bevacizumab use.
- Pregnant patient.
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab
Arm Description
Arm type to experimental based on single group assignment. Bevacizumab (trade name Avastin, Genentech/Roche) is a humanized monoclonal antibody that recognises and blocks vascular endothelial growth factor (VEGF).VEGF is a chemical signal that stimulates the growth of new blood vessels.
Outcomes
Primary Outcome Measures
Regression of corneal neovascularization
Secondary Outcome Measures
visual acuity, lipid keratopathy, side effect
Full Information
NCT ID
NCT00992849
First Posted
October 8, 2009
Last Updated
October 13, 2009
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00992849
Brief Title
Bevacizumab for the Treatment of Corneal Neovascularization
Official Title
Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the current study is to assess the efficacy and safety of the inhibitory effect of bevacizumab (Avastin) with different routes including topical and subconjunctival application on corneal neovascularization in the human eyes.
Detailed Description
The compassionate off-label use of bevacizumab as well as the potential risks, benefits, and adverse effects of this medication are discussed extensively with each patient. To further minimize systemic absorption, silicone punctual plugs are placed in the lower eyelids. One group of patients apply topical bevacizumab, 1.0%(10mg/ml), 4 times of day. The other group of patients received subconjunctival injection of bevacizumab(2.5mg/0.1ml) once. The patients are examined at 1day, 1week, 2weeks, 3weeks, and 1month, then monthly till the corneal neovascularization are gone or reduced to some degrees. Best-corrected visual acuity, slip-lamp examination, tonometry, external photography, pachymetry, specular microscopy (if possible), and systemic blood pressure are completed at all visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization
Keywords
Corneal neovascularization, bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
Arm type to experimental based on single group assignment. Bevacizumab (trade name Avastin, Genentech/Roche) is a humanized monoclonal antibody that recognises and blocks vascular endothelial growth factor (VEGF).VEGF is a chemical signal that stimulates the growth of new blood vessels.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc
Primary Outcome Measure Information:
Title
Regression of corneal neovascularization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
visual acuity, lipid keratopathy, side effect
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 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), ocular surface reconstruction , trauma, infectious or non-infectious corneal ulcer.
Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25.
Post-PSP or ocular surface reconstruction 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 mort than half a year ago and was not in the acute post-operation phase.
The patient had no active endophthalmitis, 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.
Patient that had systemic disease which was not suitable for bevacizumab use.
Pregnant patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Hsi Hsiao, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
105
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Bevacizumab for the Treatment of Corneal Neovascularization
We'll reach out to this number within 24 hrs