Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
1 other identifier
interventional
28
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 29, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedSeptember 23, 2011
September 1, 2011
3 months
August 29, 2011
September 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
At day 2 after IVB in Group 1, day 7 after IVB at group 2.
Study Arms (2)
Intravitreal Avastin Day 2
EXPERIMENTALrandomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
Intravitreal Avastin Day 7
ACTIVE COMPARATORrandomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
Interventions
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
You may qualify if:
- Patients with proliferative diabetic retinopathy who were scheduled for PPV for vitreous hemorrhage or tractional retinal detachment (TRD)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul Saint Mary's hospital
Seoul, Seoul, 137-070, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Preofessor
Study Record Dates
First Submitted
August 29, 2011
First Posted
September 23, 2011
Study Start
August 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
September 23, 2011
Record last verified: 2011-09