Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

Complications of Diabetes Mellitus Clinical Trial

Official title:

Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01439178
• Other study ID #: KC11MISI0391
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2011
• Last updated: September 21, 2011
• Start date: August 2011
• Est. completion date: November 2011

Study information

• Verified date: September 2011
• Source: Seoul St. Mary's Hospital
• Contact: Won Ki Lee, MD. Ph.D
• Phone: 82-2-2258-1188
• Email: wklee[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications of Diabetes Mellitus
• Diabetes Complications

Intervention

Drug:
• Intravitreal 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Saint Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No