Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
Recruitment status was: Recruiting
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).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Changes in best-corrected visual acuity (BCVA) [ Time Frame: from month 0 to month 6 in monthly schedule (upto 6 months) ] [ Designated as safety issue: No ]ETDRS BCVA will be measured after 6 6 serial IVB.
- amount of hard exudates detected on fundus photography [ Time Frame: from month 0 to month 6 in bimonthly schedule (upto 6 months) ] [ Designated as safety issue: No ]on fundus photography
- macular edema detected by optical coherent tomography [ Time Frame: from month 0 to month 6 in bimonthly schedule (upto 6 months) ] [ Designated as safety issue: No ]central subfield thickness will be measured.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: one arm for Anastin injection
intravitreal Avastin injection
Drug: Avastin (bevacizumab)
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422018
|Korea, Republic of|
|Seoul St Mary's hospital|
|Seocho, Seoul, Korea, Republic of, 137-070|
|Principal Investigator:||Won ki Lee, MD Ph.D||Seoul St. Mary's Hospital|