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

May 19, 2008
May 20, 2008
August 2007
February 2008   (final data collection date for primary outcome measure)
Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity [ Time Frame: prospective ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681603 on ClinicalTrials.gov Archive Site
major side effects [ Time Frame: prospective ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lipid Keratopathy
  • Penetrating Keratoplasty
  • Herpetic Keratopathy
  • Rosacea
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 )
Experimental: 1
13 cases that accepted subconjunctival injection of bevacizumab
Intervention: Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Not Provided
10 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00681603
200708015M
Yes
Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology
National Taiwan University Hospital
Not Provided
Principal Investigator: Wei-Li Chen Department of Ophthalmology, National Taiwan University Hospital
National Taiwan University Hospital
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP