Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
NCT ID: NCT01422018
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
10 participants
INTERVENTIONAL
2011-08-31
2012-02-29
Brief Summary
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Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (\< 500 µm from fovea).
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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one arm for Anastin injection
intravitreal Avastin injection
Avastin (bevacizumab)
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)
Interventions
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Avastin (bevacizumab)
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)
Eligibility Criteria
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Inclusion Criteria
2. patients with type 2 diabetes
3. central macular thickness \> 300 µm on OCT
4. eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (\< 500 µm)
5. an area of retinal thickening less than 2 disc areas in diameter
6. 67% or more of leakage associated with microaneurysms
Exclusion Criteria
2. eyes with any pharmacologic intervention on fellow eye within 6 months
3. history of ocular diseases other than diabetic retinopathy
4. surgical history other than cataract extraction with intraocular lens implantation
5. panretinal photocoagulation within 3 months of enrollment
6. media opacity
7. any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.
18 Years
70 Years
ALL
No
Sponsors
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Seoul St. Mary's Hospital
OTHER
Responsible Party
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Won Ki Lee
Pf.
Principal Investigators
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Won ki Lee, MD Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Locations
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Seoul St Mary's hospital
Seocho, 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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KC11MISI0439
Identifier Type: -
Identifier Source: org_study_id