Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion

June 16, 2008 updated by: Shahid Beheshti University of Medical Sciences
The purpose of this study is to determine whether intraocular injection of triamcinolone is effective in the treatment of macular edema in acute branch retinal vein occlusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intravitreal triamcinolone has recently been shown to have beneficial effect on chronic macular edema due to vein occlusion and preventive effect on neovascularization. Hypothetically, prevention of macular derangement by reducing the amount of edema from early phase after occlusion until restoration of collaterals seems to be helpful in these eyes. To our knowledge, no prospective randomized clinical trial, considering both macular changes and preventive effect on neovascularization has been published for intravitreal triamcinolone in acute branch retinal vein occlusion.

Study Type

Interventional

Enrollment (Anticipated)

30

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

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:

  • Eyes suffering from branch retinal vein occlusion with less than 2 months duration.

Exclusion Criteria:

  • Monocularity,
  • Previous intraocular surgery or laser therapy
  • Glaucoma or ocular hypertension
  • Significant media opacity
  • Existence of traction on the macula
  • Visual acuity ≥20/40
  • Signs of chronicity (such as cilioretinal and/or retinal shunt vessels)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Central macular thickness

Secondary Outcome Measures

Outcome Measure
Visual acuity
Intraocular pressure
Cataract progression
Retinal neovascularization

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Alireza Ramezani, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University

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

February 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

August 31, 2006

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 16, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8247

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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