Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370266
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : June 17, 2008
Information provided by:
Shahid Beheshti University of Medical Sciences

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : February 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Central macular thickness

Secondary Outcome Measures :
  1. Visual acuity
  2. Retinal neovascularization
  3. Intraocular pressure
  4. Cataract progression

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00370266

Iran, Islamic Republic of
Alireza Ramezani, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Principal Investigator: Alireza Ramezani, MD Ophthalmic Research Center of Shaheed Beheshti Medical University Identifier: NCT00370266     History of Changes
Other Study ID Numbers: 8247
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
Macular edema
Branch retinal vein occlusion
Intravitreal triamcinolone
Macular thickness
Retinal neovascularization

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action