Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

Study Overview
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Brief Summary
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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

Official Title
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Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

Conditions
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Complications of Diabetes Mellitus

Intervention / Treatment
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* Drug: Intravitreal Avastin injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravitreal Avastin Day 2<br>randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B). | Drug: Intravitreal Avastin injection<br>* 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.<br>|
| Active Comparator: Intravitreal Avastin Day 7<br>randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B). | Drug: Intravitreal Avastin injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |