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Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion (BRVO)

Primary Purpose

Branch Retinal Vein Occlusion

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Bevacizumab
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 Branch Retinal Vein Occlusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recent onset (less than 3 months) BRVO

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 bevacizumab

Intravitreal triamcinolone

Arm Description

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

central macular thickness

Full Information

First Posted
January 6, 2010
Last Updated
January 6, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Labbafinejad Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01044329
Brief Title
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion
Acronym
BRVO
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
August 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Labbafinejad Medical Center

4. Oversight

Data Monitoring Committee
Yes

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 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
Branch Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal bevacizumab
Arm Type
Active Comparator
Arm Title
Intravitreal triamcinolone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
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
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recent onset (less than 3 months) BRVO Exclusion Criteria: Any previous intervention
Facility Information:
Facility Name
Imam Hossein medical center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alireza Ramezani, Assistant professor
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 Branch Retinal Vein Occlusion

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