Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion

Branch Retinal Vein Occlusion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370266
• Other study ID #: 8247
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2006
• Last updated: June 16, 2008
• Start date: February 2003
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• Triamcinolone

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alireza Ramezani, MD	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickness
Secondary	Visual acuity
Secondary	Retinal neovascularization
Secondary	Intraocular pressure
Secondary	Cataract progression