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Bevacizumab for the Treatment of Corneal Neovascularization

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ClinicalTrials.gov Identifier: NCT00992849
Recruitment Status : Unknown
Verified October 2009 by Chang Gung Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 9, 2009
Last Update Posted : October 15, 2009
Information provided by:
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Corneal Neovascularization Drug: Bevacizumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization
Study Start Date : May 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bevacizumab
Arm type to experimental based on single group assignment. Bevacizumab (trade name Avastin, Genentech/Roche) is a humanized monoclonal antibody that recognises and blocks vascular endothelial growth factor (VEGF).VEGF is a chemical signal that stimulates the growth of new blood vessels.
Drug: Bevacizumab
Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc
Other Name: Avastin

Primary Outcome Measures :
  1. Regression of corneal neovascularization [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. visual acuity, lipid keratopathy, side effect [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00992849

Chang Gung Memorial Hospital
Taipei, Taiwan, 105
Sponsors and Collaborators
Chang Gung Memorial Hospital
Principal Investigator: Ching-Hsi Hsiao, MD Chang Gung Memorial Hospital

Responsible Party: Ching-Hsi Hsiao, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00992849     History of Changes
Other Study ID Numbers: 98-0918C
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by Chang Gung Memorial Hospital:
Corneal neovascularization

Additional relevant MeSH terms:
Neovascularization, Pathologic
Corneal Neovascularization
Pathologic Processes
Corneal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents