Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
This study has been completed.
Sponsor:
Walter Reed Army Medical Center
Collaborator:
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Michael J. Mines, MD, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00512876
First received: August 6, 2007
Last updated: October 11, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Corneal Neovascularization |
Drug: Bevacizumab (Avastin) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization |
Resource links provided by NLM:
Further study details as provided by Walter Reed Army Medical Center:
Primary Outcome Measures:
- adverse events (ocular and systemic) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- size and extent of corneal vascularization [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | August 2007 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Bevacizumab (Avastin)
Bevacizumab 10mg/mL 1 drop BID x 3 weeks
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 (<3 months) episode of corneal and ocular surface infection (bacterial, viral, fungal, or acanthamoebal)
- recent (<3 months) ocular surgery, including cataract surgery, and/or laser of any type in the study eye
- recent (<6 months) full thickness or lamellar keratoplasty
- recent (<6 months) ocular surface reconstruction, limbal auto or allograft stem cell transplantation, or amniotic membrane transplantation
- current or recent (<3 months) use of contact lens or plan to use contact lens (excluding bandage contact lens)
- current or recent (<3 months) persistent corneal epithelial defect (of at leat 14 days duration) measuring more than 1mm2
Exclusion Criteria:
- current or recent (<1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye
- current or recent (<3 months) intravitreal durg injection to the study eye.
- recent (<1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents
- uncontrolled hypertension defined as systolic blood pressure >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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512876
Locations
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307 | |
Sponsors and Collaborators
Walter Reed Army Medical Center
Massachusetts Eye and Ear Infirmary
Investigators
| Principal Investigator: | Michael J Mines, MD | Walter Reed Army Medical Center |
More Information
No publications provided
| Responsible Party: | Michael J. Mines, MD, Research Director, Ophthalmology, Walter Reed Army Medical Center |
| ClinicalTrials.gov Identifier: | NCT00512876 History of Changes |
| Other Study ID Numbers: | WRAMC WU# 07-23022 |
| Study First Received: | August 6, 2007 |
| Last Updated: | October 11, 2011 |
| Health Authority: | United States: Federal Government |
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 19, 2013