Bevacizumab for the Treatment of Corneal Neovascularization - Full Text View

Sponsor:	Chang Gung Memorial Hospital
Information provided by:	Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00992849

Purpose

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.

Condition	Intervention	Phase
Corneal Neovascularization	Drug: Bevacizumab	Phase II

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:	Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization

Resource links provided by NLM:

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:

Regression of corneal neovascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

visual acuity, lipid keratopathy, side effect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
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)

Arms	Assigned Interventions
Experimental: Bevacizumab 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.	Drug: Bevacizumab Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc Other Name: Avastin

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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), 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992849

Locations

Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 105

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

Principal Investigator:

Ching-Hsi Hsiao, MD

Chang Gung Memorial Hospital

More Information

No publications provided

Responsible Party:	Ching-Hsi Hsiao, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00992849 History of Changes
Other Study ID Numbers:	98-0918C
Study First Received:	October 8, 2009
Last Updated:	October 13, 2009
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:

Corneal neovascularization
bevacizumab

Additional relevant MeSH terms:

Neovascularization, Pathologic
Corneal Neovascularization
Metaplasia
Pathologic Processes
Corneal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors

Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012