Back to resultsIntravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravitreal injection
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring bevacizumab, diabetic macular edema, triamcinolone
Eligibility Criteria
Inclusion Criteria:
- Diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography )
Exclusion Criteria:
- history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmHg)
- an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
- systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident)
- major surgery within the prior 6 months or planned within the next 28 days
Sites / Locations
- JiWon Lim
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Intravitreal bevacizumab injection
Intravitreal Triamcinolone injection
intravitreal bavacizumab with triamcinolone
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Central macular thickness
analyzed by optical coherence tomography
Full Information
NCT ID
NCT01342159
First Posted
April 25, 2011
Last Updated
April 26, 2011
Sponsor
Hallym University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01342159
Brief Title
Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema
Official Title
Comparative Treatment of Intravitreal Bevacizumab and Triamcinolone Acetonide on Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hallym University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
One of the most frequent complications of diabetic retinopathy is diabetic macular edema. Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it was the purpose of the present study to compare these treatment effects
Detailed Description
Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
bevacizumab, diabetic macular edema, triamcinolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravitreal bevacizumab injection
Arm Type
Active Comparator
Arm Title
Intravitreal Triamcinolone injection
Arm Type
Active Comparator
Arm Title
intravitreal bavacizumab with triamcinolone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Intravitreal injection
Intervention Description
Intravitreal Injections were done under sterile conditions with topical anesthesia and insertion of a lid speculum. For the bevacizumab group, 1.25 mg (0.05 cc) bevacizumab (Avastin, made for F. Hoffmann-La Roche Ltd Basel, Switzerland by Genentech Inc., San Francisco, CA, USA) was injected intravitreally with a 30-gauge needle through the superotemporal quadrant. For the bevacizumab with triamcinolone group, in addition to intravitreal bevacizumab, 2 mg(0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally through the inferotemporal quadrant. For triamcinolone group, 2 mg (0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally.
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
baseline, 1 month, 3 months, 6month, 9 month, 12 month
Secondary Outcome Measure Information:
Title
Central macular thickness
Description
analyzed by optical coherence tomography
Time Frame
baseline, 1 month, 3 months, 6 months, 12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography )
Exclusion Criteria:
history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmHg)
an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident)
major surgery within the prior 6 months or planned within the next 28 days
Facility Information:
Facility Name
JiWon Lim
City
Chuncheon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema
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