Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion - Full Text View

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00370266

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

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

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

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Enzyme Inhibitors
Triamcinolone diacetate
Immunosuppressive Agents
Hormones
Glucocorticoids

Pharmacologic Actions
Thrombosis
Triamcinolone hexacetonide
Embolism and Thrombosis
Triamcinolone Acetonide
Therapeutic Uses
Retinal Vein Occlusion
Triamcinolone
Venous Thrombosis
Cardiovascular Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010