Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization

Study Overview
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Brief Summary
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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.

Official Title
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The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization

Conditions
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Rosacea, Lipid Keratopathy, Penetrating Keratoplasty, Herpetic Keratopathy

Intervention / Treatment
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* Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>13 cases that accepted subconjunctival injection of bevacizumab | Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)<br>* 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.<br>* Other names: bevacizumab ( Avastin );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major side effects |  | prospective | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corneal neovascularization, lipid keratopathy, penetrating keratopathy, bevacizumab, Avastin, subconjunctival injection