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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00681603

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lipid Keratopathy Penetrating Keratoplasty Herpetic Keratopathy Rosacea	Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 13 cases that accepted subconjunctival injection of bevacizumab	Drug: 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 Names: bevacizumab ( Avastin )

Arm

Intervention/Treatment

Experimental: 1

13 cases that accepted subconjunctival injection of bevacizumab

Drug: 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 Names:

bevacizumab ( Avastin )

Outcome Measures

Primary Outcome Measures

Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity [prospective]

Secondary Outcome Measures

major side effects [prospective]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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