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

• Status: Unknown status
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul St. Mary's Hospital
• Treatments: Bevacizumab

Criteria

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.