Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01439178

Enrollment

Registered

2011-09-23

Start date

2011-08-31

Completion date

2011-11-30

Last updated

2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications of Diabetes Mellitus

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

Interventions

DRUGIntravitreal Avastin injection

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactWon Ki Lee, MD. Ph.D

wklee@catholic.ac.kr82-2-2258-1188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026