Corneal NeovascularizationNCT00512876
Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
A study testing Bevacizumab (Avastin) in people with Corneal Neovascularization, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Neovascularization
- What is being tested?
- Bevacizumab (Avastin)
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
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.
- Conditions
- Corneal Neovascularization
- Being tested
- Bevacizumab (Avastin)
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (Avastin)Drug
Bevacizumab 10mg/mL 1 drop BID x 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (Ocular and Systemic)
Measured: 24 weeks
Secondary outcomes (1)
Size and Extent of Corneal Neovascularization
computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal NeovascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Responsible party
- Principal investigator, Michael J. Mines, MD, Walter Reed Army Medical Center
- Investigators
- Michael J Mines, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512876
- Sponsor's protocol ID
- WRAMC WU# 07-23022
- Status last verified
- Jul 2013
- First submitted
- 6 Aug 2007
- Last updated
- 22 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
- ClinicalTrials.gov ID
- NCT00512876
- Acronym / sponsor ID
- WRAMC WU# 07-23022
- Conditions
- Corneal Neovascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Study start
- Aug 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Posted 3 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab (Avastin)Bevacizumab 10mg/mL 1 drop BID x 3 weeks | Drug | – |
Primary outcome
Adverse Events (Ocular and Systemic)
Time frame: 24 weeks
1 secondary outcome
Size and Extent of Corneal Neovascularization
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Mines, MD principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab (Avastin) in people with Corneal Neovascularization, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (Ocular and Systemic) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2013.