Clinical trial NCT00681603: Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
Official title: The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Keratopathy
Penetrating Keratoplasty
Herpetic Keratopathy
Rosacea
Keywords: corneal neovascularization
lipid keratopathy
penetrating keratopathy
bevacizumab
Avastin
subconjunctival injection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 13
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 study is to report the treatment outcome of subconjunctival injection of bevacizumab in patients with corneal neovascularization.
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.


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), 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

Primary outcomes:
measure: Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity
timeFrame: prospective
Secondary outcomes:
measure: major side effects
timeFrame: prospective
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Ophthalmology, National Taiwan University Hospital,
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Li Chen
role: PRINCIPAL_INVESTIGATOR
References: