Bevacizumab for the Treatment of Corneal Neovascularization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Chang Gung Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00992849
First received: October 8, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Corneal Neovascularization
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Regression of corneal neovascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • visual acuity, lipid keratopathy, side effect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: May 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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), 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00992849

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

No publications provided

Responsible Party: Ching-Hsi Hsiao, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00992849     History of Changes
Other Study ID Numbers: 98-0918C
Study First Received: October 8, 2009
Last Updated: October 13, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Corneal neovascularization
bevacizumab

Additional relevant MeSH terms:
Corneal Neovascularization
Neovascularization, Pathologic
Corneal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014