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

Diabetes Complications Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01422018
• Other study ID #: KC11MISI0439
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2011
• Last updated: September 22, 2011
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: September 2011
• Source: Seoul St. Mary's Hospital
• Contact: Sohee Jeon, MD
• Phone: 82-10-7176-1357
• Email: soheeeee[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Complications

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul St Mary's hospital	Seocho	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in best-corrected visual acuity (BCVA)	ETDRS BCVA will be measured after 6 6 serial IVB.	from month 0 to month 6 in monthly schedule (upto 6 months)	No
Secondary	amount of hard exudates detected on fundus photography	on fundus photography	from month 0 to month 6 in bimonthly schedule (upto 6 months)	No
Secondary	macular edema detected by optical coherent tomography	central subfield thickness will be measured.	from month 0 to month 6 in bimonthly schedule (upto 6 months)	No