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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681603
First Posted: May 21, 2008
Last Update Posted: May 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
  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.

Condition Intervention
Lipid Keratopathy Penetrating Keratoplasty Herpetic Keratopathy Rosacea Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity [ Time Frame: prospective ]

Secondary Outcome Measures:
  • major side effects [ Time Frame: prospective ]

Enrollment: 13
Study Start Date: August 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: bevacizumab ( Avastin )

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681603


Locations
Taiwan
Department of Ophthalmology, National Taiwan University Hospital,
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wei-Li Chen National Taiwan University Hospital
  More Information

Responsible Party: Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00681603     History of Changes
Other Study ID Numbers: 200708015M
First Submitted: May 19, 2008
First Posted: May 21, 2008
Last Update Posted: May 21, 2008
Last Verified: August 2007

Keywords provided by National Taiwan University Hospital:
corneal neovascularization
lipid keratopathy
penetrating keratopathy
bevacizumab
Avastin
subconjunctival injection

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents