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

Seoul St. Mary's Hospital

Status: Unknown

Conditions: Diabetes Complications

Treatments: Drug: Avastin (bevacizumab)

Study type: Interventional

Funder types: Other

Identifiers

NCT01422018

KC11MISI0439

Details and patient eligibility

About

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

one arm for Anastin injection

Experimental group

Description:

intravitreal Avastin injection

Treatment:

Drug: Avastin (bevacizumab)