Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00370266
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 58
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Branch Retinal Vein Occlusion	Drug: Triamcinolone	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. Central macular thickness []

Secondary Outcome Measures

1. Visual acuity []

2. Retinal neovascularization []

3. Intraocular pressure []

4. Cataract progression []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alireza Ramezani, MD	Tehran		Iran, Islamic Republic of	16666

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00370266
• Other Study ID Numbers: 8247
• First Posted: Aug 31, 2006
• Last Update Posted: Jun 17, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Macular edema; Branch retinal vein occlusion; Intravitreal triamcinolone; Macular thickness; Retinal neovascularization
• Additional relevant MeSH terms: Retinal Vein Occlusion; Triamcinolone

Study Results

No Results Posted as of Jun 17, 2008