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Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion (BRVO)

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ClinicalTrials.gov Identifier: NCT01044329
Recruitment Status : Unknown
Verified January 2010 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 7, 2010
Last Update Posted : January 7, 2010
Sponsor:
Collaborator:
Labbafinejad Medical Center
Information provided by:
Shahid Beheshti University of Medical Sciences

Study Description
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Brief Summary:
This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.

Condition or disease Intervention/treatment Phase
Branch Retinal Vein Occlusion Drug: Bevacizumab Drug: Triamcinolone Acetonide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion
Study Start Date : January 2010
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intravitreal bevacizumab Drug: Bevacizumab
Intravitreal, 1.25 mg, 3 times, one month apart.
Active Comparator: Intravitreal triamcinolone Drug: Triamcinolone Acetonide
Intravitreal, 2 mg, 2 times, two months apart.


Outcome Measures
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Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. central macular thickness [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent onset (less than 3 months) BRVO

Exclusion Criteria:

  • Any previous intervention
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01044329


Locations
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Iran, Islamic Republic of
Imam Hossein medical center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Alireza Ramezani, Assistant professor       arramezani@gmail.com   
Principal Investigator: Alireza Ramezani, Assistant professor         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Labbafinejad Medical Center
More Information
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Responsible Party: Alireza ramezani, Ophthamic research center
ClinicalTrials.gov Identifier: NCT01044329    
Other Study ID Numbers: 8900
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Bevacizumab
Triamcinolone diacetate
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action