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

January 6, 2010 updated by: Shahid Beheshti University of Medical Sciences

Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Imam Hossein medical center
        • Principal Investigator:
          • Alireza Ramezani, Assistant professor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recent onset (less than 3 months) BRVO

Exclusion Criteria:

  • Any previous intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravitreal triamcinolone
Drug: Triamcinolone Acetonide
Intravitreal, 2 mg, 2 times, two months apart.
Active Comparator: Intravitreal bevacizumab
Drug: Bevacizumab
Intravitreal, 1.25 mg, 3 times, one month apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
central macular thickness
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Collaborators

Labbafinejad Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8900

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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