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

Primary Purpose

Diabetes Complications

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Avastin (bevacizumab)
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring clinically significant macular edema, diabetic macular edema, focal edema, focal laser photocoagulation, hard exudates, intravitreal bevacizumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul St Mary's hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one arm for Anastin injection

Arm Description

intravitreal Avastin injection

Outcomes

Primary Outcome Measures

Changes in best-corrected visual acuity (BCVA)
ETDRS BCVA will be measured after 6 6 serial IVB.

Secondary Outcome Measures

amount of hard exudates detected on fundus photography
on fundus photography
macular edema detected by optical coherent tomography
central subfield thickness will be measured.

Full Information

First Posted
August 5, 2011
Last Updated
September 22, 2011
Sponsor
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01422018
Brief Title
Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications
Keywords
clinically significant macular edema, diabetic macular edema, focal edema, focal laser photocoagulation, hard exudates, intravitreal bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
one arm for Anastin injection
Arm Type
Experimental
Arm Description
intravitreal Avastin injection
Intervention Type
Drug
Intervention Name(s)
Avastin (bevacizumab)
Intervention Description
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)
Primary Outcome Measure Information:
Title
Changes in best-corrected visual acuity (BCVA)
Description
ETDRS BCVA will be measured after 6 6 serial IVB.
Time Frame
from month 0 to month 6 in monthly schedule (upto 6 months)
Secondary Outcome Measure Information:
Title
amount of hard exudates detected on fundus photography
Description
on fundus photography
Time Frame
from month 0 to month 6 in bimonthly schedule (upto 6 months)
Title
macular edema detected by optical coherent tomography
Description
central subfield thickness will be measured.
Time Frame
from month 0 to month 6 in bimonthly schedule (upto 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients of either gender aged > 18 years patients with type 2 diabetes central macular thickness > 300 µm on OCT eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (< 500 µm) an area of retinal thickening less than 2 disc areas in diameter 67% or more of leakage associated with microaneurysms Exclusion Criteria: eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye eyes with any pharmacologic intervention on fellow eye within 6 months history of ocular diseases other than diabetic retinopathy surgical history other than cataract extraction with intraocular lens implantation panretinal photocoagulation within 3 months of enrollment media opacity any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohee Jeon, MD
Phone
82-10-7176-1357
Email
soheeeee@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Won ki Lee, DM, Ph.D
Phone
82-2-2258-1188
Email
wklee@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won ki Lee, MD Ph.D
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St Mary's hospital
City
Seocho
State/Province
Seoul
ZIP/Postal Code
137-070
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohee Jeon, MD
Phone
82-10-7176-1357
Email
soheeeee@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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