Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision

January 20, 2010 updated by: Hallym University Medical Center
To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: triamcinolone
Procedure: intravitreal injection
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection
Active Comparator: bevacizumab
intravitreal bevacizumab or triamcinolone determined by single physician
Procedure: intravitreal injection
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
best corrected visual acuity
Time Frame: baseline, 1 month, 2 months, 3 months, 6 months, 12 months
baseline, 1 month, 2 months, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
central macular thickness by optical coherence tomography
Time Frame: baseline, 1 month, 2 months, 3 months, 6 months 12months
baseline, 1 month, 2 months, 3 months, 6 months 12months

Collaborators and Investigators

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

Sponsor

Hallym University 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, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 22, 2010

Last Update Submitted That Met QC Criteria

January 20, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009_10_12

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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