Back to resultsIntravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion
Primary Purpose
Branch Retinal Vein Occlusion
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring Macular edema, Branch retinal vein occlusion, Intravitreal triamcinolone, Macular thickness, Retinal neovascularization
Eligibility Criteria
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)
Sites / Locations
- Alireza Ramezani, MD
Outcomes
Primary Outcome Measures
Central macular thickness
Secondary Outcome Measures
Visual acuity
Retinal neovascularization
Intraocular pressure
Cataract progression
Full Information
NCT ID
NCT00370266
First Posted
August 30, 2006
Last Updated
June 16, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00370266
Brief Title
Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion
Keywords
Macular edema, Branch retinal vein occlusion, Intravitreal triamcinolone, Macular thickness, Retinal neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Primary Outcome Measure Information:
Title
Central macular thickness
Secondary Outcome Measure Information:
Title
Visual acuity
Title
Retinal neovascularization
Title
Intraocular pressure
Title
Cataract progression
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Ramezani, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alireza Ramezani, MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion
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