Overview

This trial is active, not recruiting.

Condition corneal neovascularization
Treatment bevacizumab
Phase phase 2
Target VEGF
Sponsor Chang Gung Memorial Hospital
Start date May 2009
End date April 2010
Trial size 10 participants
Trial identifier NCT00992849, 98-0918C

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
bevacizumab Avastin
Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc

Primary Outcomes

Measure
Regression of corneal neovascularization
time frame: 6 months

Secondary Outcomes

Measure
visual acuity, lipid keratopathy, side effect
time frame: 6 months

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization
Principal investigator Ching-Hsi Hsiao, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Chang Gung Memorial Hospital.