Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Central Retinal Vein Occlusion (CRVO)
Primary Purpose
Central Retinal Vein Occlusion
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Bevasizumab
Triamcinolone Acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Central Retinal Vein Occlusion
Eligibility Criteria
Inclusion Criteria:
- Recent onset (less than 3 months) central retinal vein occlusion
Exclusion Criteria:
- Any previous intervention
Sites / Locations
- Imam Hossein medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intravitreal triamcinolone
Intravitreal bevasizumab
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
central macular thickness
Full Information
NCT ID
NCT01178697
First Posted
August 2, 2010
Last Updated
August 9, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Ophthalmic Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01178697
Brief Title
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Central Retinal Vein Occlusion (CRVO)
Official Title
Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Ophthalmic Research Center
4. Oversight
5. Study Description
Brief Summary
This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute central retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Investigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Intravitreal triamcinolone
Arm Type
Active Comparator
Arm Title
Intravitreal bevasizumab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bevasizumab
Intervention Description
Intravitreal, 1.25 mg, 3 times, one month apart.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
Intravitreal, 2 mg, 2 times, two months apart.
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
central macular thickness
Time Frame
6 months
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
Recent onset (less than 3 months) central retinal vein occlusion
Exclusion Criteria:
Any previous intervention
Facility Information:
Facility Name
Imam Hossein medical center
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alireza Ramezani, Assistant professor
Phone
+98 21 22585952
Email
arramezani@gmail.com
First Name & Middle Initial & Last Name & Degree
Alireza Ramezani, Assistant professor
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Central Retinal Vein Occlusion (CRVO)
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