Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

Seoul St. Mary's Hospital

Status: Unknown

Conditions: Complications of Diabetes Mellitus

Treatments: Drug: Intravitreal Avastin injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01439178

KC11MISI0391

Details and patient eligibility

About

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

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Intravitreal Avastin Day 2

Experimental group

Description:

randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).

Treatment:

Drug: Intravitreal Avastin injection

Intravitreal Avastin Day 7

Active Comparator group

Description:

randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).

Treatment:

Drug: Intravitreal Avastin injection