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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00681603
First received: May 19, 2008
Last updated: May 20, 2008
Last verified: August 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • major side effects [ Time Frame: prospective ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   10 Years to 70 Years
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Department of Ophthalmology, National Taiwan University Hospital
  More Information

No publications provided

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
Study First Received: May 19, 2008
Last Updated: May 20, 2008
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
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 November 19, 2014