- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00370266
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
-
-
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Tehran, Iran, Islamic Republic of, 16666
- Alireza Ramezani, MD
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-
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 |
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Central macular thickness
|
Secondary Outcome Measures
Outcome Measure |
---|
Visual acuity
|
Intraocular pressure
|
Cataract progression
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Retinal neovascularization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
Clinical Trials on Branch Retinal Vein Occlusion
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University of TorontoOntario Research FundUnknownCentral Retinal Vein Occlusion | Branch Retinal Vein Occlusion | Central Retinal Artery Occlusion | Branch Retinal Artery OcclusionCanada
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University of TorontoPfizer; Unity Health Toronto; Canadian Heart Research Centre; Ontario Association... and other collaboratorsUnknownThrombosis | Central Retinal Vein Occlusion | Retinal Vein Occlusion | Branch Retinal Vein Occlusion | Retinal Vein ThrombosisCanada
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Palo Alto Medical FoundationTerminatedCentral Retinal Vein Occlusion | Branch Retinal Vein OcclusionUnited States
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Shahid Beheshti University of Medical SciencesLabbafinejad Medical CenterUnknownBranch Retinal Vein OcclusionIran, Islamic Republic of
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-
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