Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
NCT ID: NCT01439178
Last Updated: 2011-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2011-08-31
2011-11-30
Brief Summary
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Design: Prospective, open-label, controlled, randomized interventional clinical trial.
Participants: Twenty eyes of 28 consecutive patients who are scheduled for pars plana vitrectomy (ppV) for proliferative diabetic retinopathy were prospectively enrolled.
Methods: All patients were randomly assigned to receive IVB either at 2 or 7 days before ppV. Aqueous humor samples were taken from anterior chamber just before IVB and at the time of surgery. Multiplex cytokine array were used to assay various cytokines
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intravitreal Avastin Day 2
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
Intravitreal Avastin injection
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA) will be injected through the pars plana at 3.5 mm from the limbus, using 30 gauge needle.
Intravitreal Avastin Day 7
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
Intravitreal Avastin injection
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA) will be injected through the pars plana at 3.5 mm from the limbus, using 30 gauge needle.
Interventions
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Intravitreal Avastin injection
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA) will be injected through the pars plana at 3.5 mm from the limbus, using 30 gauge needle.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Eyes with panretinal photocoagulation on study eye within 3 months
* Eyes with any pharmacologic intervention on fellow eye within 3 months,
* History of ocular diseases other than diabetic retinopathy
* History of PPV on study eye
* History of systemic thromboembolic events including myocardial infarction and cerebrovascular accidents.
18 Years
80 Years
ALL
No
Sponsors
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Seoul St. Mary's Hospital
OTHER
Responsible Party
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Won Ki Lee
Preofessor
Locations
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Seoul Saint Mary's hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KC11MISI0391
Identifier Type: -
Identifier Source: org_study_id