Bevacizumab for the Treatment of Corneal Neovascularization
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Chang Gung Memorial Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Chang Gung Memorial Hospital
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00992849
First received: October 8, 2009
Last updated: October 13, 2009
Last verified: October 2009
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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 2 |
| 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:
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 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 May 21, 2013