Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
NCT ID: NCT00681603
Last Updated: 2008-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2007-08-31
2008-02-29
Brief Summary
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2. 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.
3. Main outcome measurements: resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
13 cases that accepted subconjunctival injection of bevacizumab
subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
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.
Interventions
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subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
10 Years
70 Years
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University, Department of Ophthalmology
Principal Investigators
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Wei-Li Chen
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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Department of Ophthalmology, National Taiwan University Hospital,
Taipei, Taipei, Taiwan
Countries
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Other Identifiers
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200708015M
Identifier Type: -
Identifier Source: org_study_id