Back to resultsAcute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
Primary Purpose
Complications of Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravitreal Avastin injection
Sponsored by
About this trial
This is an interventional treatment trial for Complications of Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Patients with proliferative diabetic retinopathy who were scheduled for PPV for vitreous hemorrhage or tractional retinal detachment (TRD)
Exclusion Criteria:
- Eyes with any pharmacologic intervention on study eye within 6 months
- 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.
Sites / Locations
- Seoul Saint Mary's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intravitreal Avastin Day 2
Intravitreal Avastin Day 7
Arm Description
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
Outcomes
Primary Outcome Measures
intraocular VEGF levels (pg/ml) in both groups (measured in aqueous humor), using multiplex beads immunoassay
Because we want to compare the differences between day 2 and day 7, vitrectomy will be performed at day 2 in group 1 and day 7 in group 2.
That's why the time frame has two time point
Secondary Outcome Measures
Full Information
NCT ID
NCT01439178
First Posted
August 29, 2011
Last Updated
September 21, 2011
Sponsor
Seoul St. Mary's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01439178
Brief Title
Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
Official Title
Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purpose: To evaluate the acute changes in intraocular cytokines after intravitreal bevacizumab (IVB) in proliferative diabetic retinopathy.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications of Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravitreal Avastin Day 2
Arm Type
Experimental
Arm Description
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
Arm Title
Intravitreal Avastin Day 7
Arm Type
Active Comparator
Arm Description
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
Intervention Type
Drug
Intervention Name(s)
Intravitreal Avastin injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
intraocular VEGF levels (pg/ml) in both groups (measured in aqueous humor), using multiplex beads immunoassay
Description
Because we want to compare the differences between day 2 and day 7, vitrectomy will be performed at day 2 in group 1 and day 7 in group 2.
That's why the time frame has two time point
Time Frame
At day 2 after IVB in Group 1, day 7 after IVB at group 2.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with proliferative diabetic retinopathy who were scheduled for PPV for vitreous hemorrhage or tractional retinal detachment (TRD)
Exclusion Criteria:
Eyes with any pharmacologic intervention on study eye within 6 months
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Ki Lee, MD. Ph.D
Phone
82-2-2258-1188
Email
wklee@catholic.ac.kr
Facility Information:
Facility Name
Seoul Saint Mary's hospital
City
Seoul
ZIP/Postal Code
137-070
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won ki Lee, M.D. Ph.D
Phone
82-2-2258-1188
Email
wklee@catholic.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
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