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Completed

NCT Number: NCT00681603

Safety and Effectiveness of Subconjunctival Injection of Bevacizumab 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.

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Key information

Age range

10 year–70 year

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, National Taiwan University Hospital,

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)

Drug

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 names: bevacizumab ( Avastin )

Primary outcomes

  1. Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity

    Time frame: prospective

Secondary outcomes

  1. major side effects

    Time frame: prospective

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 21, 2008
Registry last updated
May 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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