N/A
N=24
Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Corneal Neovascularization
Bottom Line
View on ClinicalTrials.gov: NCT00512876 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Adverse Events (Ocular and Systemic) — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bevacizumab (Avastin) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Walter Reed Army Medical Center
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events (Ocular and Systemic) |
— | — |
| SECONDARY Size and Extent of Corneal Neovascularization |
27.9 | — |
Summary
Purpose: To determine the efficacy and safety of one commonly used VEGF inhibitor, bevacizumab (Avastin, Genentech), as a topical agent for the treatment of corneal neovascularization.
Eligibility Criteria
Inclusion Criteria
- male or female, at least 18 years of age
- clinically stable corneal neovascularization
- superficial or deep corneal neovascularization that extends farther than 2mm from the limbus
- ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits.
Clinical stability - all of the following criterial should be excluded before a corneal neovascularization can be regarded as clinically stable:
- current or recent ( 150 mmHg or diastolic blood pressure of >90 mmHg
- history of a thromboembolic event, including myocardial infarction or cerebral vascular accident
- patients age 75 or older
- history of renal abnormalities
- recent (<3 months) or planned surgery
- history of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin or similar anticoagulant agent)
- all female patients of childbearing potential will be excluded. A female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.
- any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
- any condition that precludes the patient's ability or an assisting family member's ability to apply the medication drops or to sustain five minutes of pressure on the lacrimal ducts after drop application.
- concurrent enrollment in another clinical investigation medicinal product or device study is prohibited.
Data sourced from ClinicalTrials.gov (NCT00512876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.