Status:
COMPLETED
Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Lipid Keratopathy
Penetrating Keratoplasty
Eligibility:
10-70 years
Phase:
NA
Brief Summary
1. 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00681603
Start Date
August 1 2007
End Date
February 1 2008
Last Update
May 21 2008
Active Locations (1)
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1
Department of Ophthalmology, National Taiwan University Hospital,
Taipei, Taipei, Taiwan, 100