Bevacizumab for the Treatment of Corneal Neovascularization
Recruitment status was Active, not recruiting
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.
|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|
- Regression of corneal neovascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- visual acuity, lipid keratopathy, side effect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|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)|
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.
Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc
Other Name: Avastin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992849
|Chang Gung Memorial Hospital|
|Taipei, Taiwan, 105|
|Principal Investigator:||Ching-Hsi Hsiao, MD||Chang Gung Memorial Hospital|