Back to resultsTriamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
Primary Purpose
Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity
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 Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity focused on measuring bevacizumab,triamcinolone, intravitreal injection
Eligibility Criteria
Inclusion Criteria:
- central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion
Exclusion Criteria:
- previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
- Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
- neovascularization on the disc or elsewhere or rubeosis
Sites / Locations
- keoung ik Na
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bevacizumab
triamcinolone
Arm Description
intravitreal bevacizumab or triamcinolone determined by single physician
Outcomes
Primary Outcome Measures
best corrected visual acuity
Secondary Outcome Measures
central macular thickness by optical coherence tomography
Full Information
NCT ID
NCT01053858
First Posted
January 14, 2010
Last Updated
January 20, 2010
Sponsor
Hallym University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01053858
Brief Title
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hallym University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity
Keywords
bevacizumab,triamcinolone, intravitreal injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bevacizumab
Arm Type
Active Comparator
Arm Description
intravitreal bevacizumab or triamcinolone determined by single physician
Arm Title
triamcinolone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
intravitreal injection
Intervention Description
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection
Primary Outcome Measure Information:
Title
best corrected visual acuity
Time Frame
baseline, 1 month, 2 months, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
central macular thickness by optical coherence tomography
Time Frame
baseline, 1 month, 2 months, 3 months, 6 months 12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion
Exclusion Criteria:
previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
neovascularization on the disc or elsewhere or rubeosis
Facility Information:
Facility Name
keoung ik Na
City
Chuncheon
State/Province
Anyang
ZIP/Postal Code
135-060
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
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