Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
This study has been completed.
Sponsor:
National Taiwan University Hospital
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00681603
First received: May 19, 2008
Last updated: May 20, 2008
Last verified: August 2007
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Purpose
- 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.
- 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.
- Main outcome measurements: resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity.
| Condition | Intervention |
|---|---|
|
Lipid Keratopathy Penetrating Keratoplasty Herpetic Keratopathy Rosacea |
Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg) |
| 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: | The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity [ Time Frame: prospective ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- major side effects [ Time Frame: prospective ] [ Designated as safety issue: Yes ]
| Enrollment: | 13 |
| Study Start Date: | August 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
13 cases that accepted subconjunctival injection of bevacizumab
|
Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
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 Name: bevacizumab ( Avastin )
|
Eligibility| Ages Eligible for Study: | 10 Years to 70 Years |
| 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), 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681603
Locations
| Taiwan | |
| Department of Ophthalmology, National Taiwan University Hospital, | |
| Taipei, Taiwan, 100 | |
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
| Principal Investigator: | Wei-Li Chen | Department of Ophthalmology, National Taiwan University Hospital, |
More Information
No publications provided
| Responsible Party: | Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology |
| ClinicalTrials.gov Identifier: | NCT00681603 History of Changes |
| Other Study ID Numbers: | 200708015M |
| Study First Received: | May 19, 2008 |
| Last Updated: | May 20, 2008 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
corneal neovascularization lipid keratopathy penetrating keratopathy |
bevacizumab Avastin subconjunctival injection |
Additional relevant MeSH terms:
|
Rosacea Skin 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 23, 2013