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

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681603
• Other study ID #: 200708015M
• Status: Completed
• Phase: N/A
• First received: May 19, 2008
• Last updated: May 20, 2008
• Start date: August 2007
• Est. completion date: February 2008

Study information

• Verified date: August 2007
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 70 Years

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), 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

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

• Herpetic Keratopathy
• Lipid Keratopathy
• Penetrating Keratoplasty
• Rosacea

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Ophthalmology, National Taiwan University Hospital,	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity		prospective	No
Secondary	major side effects		prospective	Yes