Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

Not Applicable

• Conditions: Complications of Diabetes Mellitus
• Interventions: Drug: Intravitreal Avastin injection

• Registration Number: NCT01439178
• Lead Sponsor: Seoul St. Mary's Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-29
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-21
• Last Update Submitted: 2011-09-21
• Study First Posted: 2011-09-23
• Last Update Posted: 2011-09-23
• Primary Completion: 2011-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravitreal Avastin Day 2	Intravitreal Avastin injection	randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
Intravitreal Avastin Day 7	Intravitreal Avastin injection	randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).

Primary Outcome Measures

Name	Time	Method
intraocular VEGF levels (pg/ml) in both groups (measured in aqueous humor), using multiplex beads immunoassay	At day 2 after IVB in Group 1, day 7 after IVB at group 2.	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

Trial Locations

Locations (1)

Seoul Saint Mary's hospital; 🇰🇷 Seoul, Korea, Republic of