Clinical trial NCT00992849: Bevacizumab for the Treatment of Corneal Neovascularization
Official title: Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Corneal Neovascularization
Keywords: Corneal neovascularization
bevacizumab
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to assess the efficacy and safety of the inhibitory effect of bevacizumab (Avastin) with different routes including topical and subconjunctival application on corneal neovascularization in the human eyes.

Detailed description: The compassionate off-label use of bevacizumab as well as the potential risks, benefits, and adverse effects of this medication are discussed extensively with each patient. To further minimize systemic absorption, silicone punctual plugs are placed in the lower eyelids. One group of patients apply topical bevacizumab, 1.0%(10mg/ml), 4 times of day. The other group of patients received subconjunctival injection of bevacizumab(2.5mg/0.1ml) once. The patients are examined at 1day, 1week, 2weeks, 3weeks, and 1month, then monthly till the corneal neovascularization are gone or reduced to some degrees. Best-corrected visual acuity, slip-lamp examination, tonometry, external photography, pachymetry, specular microscopy (if possible), and systemic blood pressure are completed at all visits.

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), ocular surface reconstruction , trauma, infectious or non-infectious corneal ulcer.
* Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25.
* Post-PSP or ocular surface reconstruction 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 mort than half a year ago and was not in the acute post-operation phase.
* The patient had no active endophthalmitis, 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.
* Patient that had systemic disease which was not suitable for bevacizumab use.
* Pregnant patient.

Primary outcomes:
measure: Regression of corneal neovascularization
timeFrame: 6 months
Secondary outcomes:
measure: visual acuity, lipid keratopathy, side effect
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-Hsi Hsiao, MD
role: PRINCIPAL_INVESTIGATOR
References: