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| 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization |
| 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 |
|---|---|
|
Bevacizumab: 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.
|
Drug: Bevacizumab
Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Chang Gung Memorial Hospital ( Ching-Hsi Hsiao ) |
| Study ID Numbers: | 98-0918C |
| Study First Received: | October 8, 2009 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00992849 History of Changes |
| Health Authority: | Taiwan: Institutional Review Board |
|
Corneal neovascularization bevacizumab |
|
Corneal Diseases Antineoplastic Agents Eye Diseases Growth Substances Physiological Effects of Drugs Bevacizumab Corneal Neovascularization Angiogenesis Inhibitors |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Metaplasia Neovascularization, Pathologic Angiogenesis Modulating Agents Growth Inhibitors |