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

Not Applicable

• Conditions: Diabetes Complications
• Interventions: Drug: Avastin (bevacizumab)

• Registration Number: NCT01422018
• Lead Sponsor: Seoul St. Mary's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-22
• Last Update Posted: 2011-09-23
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. patients of either gender aged > 18 years
2. patients with type 2 diabetes
3. central macular thickness > 300 µm on OCT
4. eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (< 500 µm)
5. an area of retinal thickening less than 2 disc areas in diameter
6. 67% or more of leakage associated with microaneurysms

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one arm for Anastin injection	Avastin (bevacizumab)	intravitreal Avastin injection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

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