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...
Date First Received: August 30, 2006
Last Updated: June 16, 2008
Verified by: Shaheed Beheshti Medical University, June 2008
Clinical Trial Phase: Phase 2 | Start Date: February 2003
Overall Status: Completed
Estimated Enrollment: 30
Brief Summary
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: October 2007
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Triamcinolone
Outcome Measures for this Clinical Trial
Primary Measures
- Central macular thickness
Secondary Measures
- Visual acuity
- Retinal neovascularization
- Intraocular pressure
- Cataract progression
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Shaheed Beheshti Medical University
Overall Clinical Trial Officials and Contacts
Alireza Ramezani, MD Principal Investigator Ophthalmic Research Center of Shaheed Beheshti Medical University
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00370266
Study ID Number: 8247
ClinicalTrials.gov Identifier: NCT00370266
Health Authority: Iran: Ethics Committee
Clinical Trials Authorship and Review
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