Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
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|ClinicalTrials.gov Identifier: NCT01422018|
Recruitment Status : Unknown
Verified September 2011 by Won Ki Lee, Seoul St. Mary's Hospital.
Recruitment status was: Recruiting
First Posted : August 23, 2011
Last Update Posted : September 23, 2011
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).
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Complications||Drug: Avastin (bevacizumab)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||February 2012|
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)
- Changes in best-corrected visual acuity (BCVA) [ Time Frame: from month 0 to month 6 in monthly schedule (upto 6 months) ]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) ]on fundus photography
- macular edema detected by optical coherent tomography [ Time Frame: from month 0 to month 6 in bimonthly schedule (upto 6 months) ]central subfield thickness will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422018
|Contact: Sohee Jeon, MDemail@example.com|
|Contact: Won ki Lee, DM, Ph.Dfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul St Mary's hospital||Recruiting|
|Seocho, Seoul, Korea, Republic of, 137-070|
|Contact: Sohee Jeon, MD 82-10-7176-1357 email@example.com|
|Principal Investigator:||Won ki Lee, MD Ph.D||Seoul St. Mary's Hospital|