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

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

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.

Study Overview

• Status: Completed
• Conditions: Rosacea; Penetrating Keratoplasty; Lipid Keratopathy; Herpetic Keratopathy
• Intervention / Treatment: Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Department of Ophthalmology, National Taiwan University Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity	prospective

Secondary Outcome Measures

Outcome Measure	Time Frame
major side effects	prospective

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: May 19, 2008
• First Submitted That Met QC Criteria: May 20, 2008
• First Posted (ESTIMATE): May 21, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 21, 2008
• Last Update Submitted That Met QC Criteria: May 20, 2008
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Keywords: bevacizumab; Avastin; corneal neovascularization; subconjunctival injection; lipid keratopathy; penetrating keratopathy
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: 200708015M