Diabetes Complications
Conditions
Keywords
clinically significant macular edema, diabetic macular edema, focal edema, focal laser photocoagulation, hard exudates, intravitreal bevacizumab
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).
Interventions
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)
Sponsors
Seoul St. Mary's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactSohee Jeon, MD
Backup ContactWon ki Lee, DM, Ph.D
Outcome results
None listed