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Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370266
First received: August 30, 2006
Last updated: June 16, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention Phase
Branch Retinal Vein Occlusion
 Drug: Triamcinolone
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • Central macular thickness

Secondary Outcome Measures:
  • Visual acuity
  • Retinal neovascularization
  • Intraocular pressure
  • Cataract progression

Estimated Enrollment: 30
Study Start Date: February 2003
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370266

Locations
Iran, Islamic Republic of
Alireza Ramezani, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shaheed Beheshti Medical University
Investigators
Principal Investigator: Alireza Ramezani, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00370266     History of Changes
Other Study ID Numbers: 8247
Study First Received: August 30, 2006
Last Updated: June 16, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:
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
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013