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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Seoul St. Mary's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Won Ki Lee, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01422018
First received: August 5, 2011
Last updated: September 22, 2011
Last verified: September 2011

August 5, 2011
September 22, 2011
August 2011
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01422018 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
Not Provided

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).

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Complications
Drug: Avastin (bevacizumab)
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)
Experimental: one arm for Anastin injection
intravitreal Avastin injection
Intervention: Drug: Avastin (bevacizumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Sohee Jeon, MD 82-10-7176-1357 soheeeee@gmail.com
Contact: Won ki Lee, DM, Ph.D 82-2-2258-1188 wklee@catholic.ac.kr
Korea, Republic of
 
NCT01422018
KC11MISI0439
Yes
Won Ki Lee, Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
Not Provided
Principal Investigator: Won ki Lee, MD Ph.D Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP