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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
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

First Posted
August 2, 2010
Last Updated
August 9, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Ophthalmic Research Center
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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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