Bevacizumab for the Treatment of Corneal Neovascularization

Corneal Neovascularization Clinical Trial

Official title:

Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00992849
• Other study ID #: 98-0918C
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 8, 2009
• Last updated: October 13, 2009
• Start date: May 2009
• Est. completion date: April 2012

Study information

• Verified date: October 2009
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 2012
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• Bevacizumab
Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression of corneal neovascularization		6 months	No
Secondary	visual acuity, lipid keratopathy, side effect		6 months	Yes