Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy

Sponsor

Seoul St. Mary's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01422018

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy.

Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Complications	Drug: Avastin (bevacizumab)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2012

Anticipated Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: one arm for Anastin injection intravitreal Avastin injection	Drug: Avastin (bevacizumab) Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)

Arm

Intervention/Treatment

Experimental: one arm for Anastin injection

intravitreal Avastin injection

Drug: Avastin (bevacizumab)

Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)

Outcome Measures

Primary Outcome Measures

Changes in best-corrected visual acuity (BCVA) [from month 0 to month 6 in monthly schedule (upto 6 months)]
ETDRS BCVA will be measured after 6 6 serial IVB.

Secondary Outcome Measures

amount of hard exudates detected on fundus photography [from month 0 to month 6 in bimonthly schedule (upto 6 months)]
on fundus photography
macular edema detected by optical coherent tomography [from month 0 to month 6 in bimonthly schedule (upto 6 months)]
central subfield thickness will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients of either gender aged > 18 years
patients with type 2 diabetes
central macular thickness > 300 µm on OCT
eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (< 500 µm)
an area of retinal thickening less than 2 disc areas in diameter
67% or more of leakage associated with microaneurysms

Exclusion Criteria:

eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye
eyes with any pharmacologic intervention on fellow eye within 6 months
history of ocular diseases other than diabetic retinopathy
surgical history other than cataract extraction with intraocular lens implantation
panretinal photocoagulation within 3 months of enrollment
media opacity
any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.