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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Shaheed Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Labbafinejad Medical Center
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01044329
First received: January 6, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention Phase
Branch Retinal Vein Occlusion
 Drug: Bevacizumab
Drug: Triamcinolone Acetonide
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • central macular thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent onset (less than 3 months) BRVO

Exclusion Criteria:

  • Any previous intervention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044329

Locations
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
Shaheed Beheshti Medical University
Labbafinejad Medical Center
  More Information

No publications provided

Responsible Party: Alireza ramezani, Ophthamic research center
ClinicalTrials.gov Identifier: NCT01044329     History of Changes
Other Study ID Numbers: 8900
Study First Received: January 6, 2010
Last Updated: January 6, 2010
Health Authority: Iran: Ophthalmic research center of Labbafinejad Medical Center

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
Bevacizumab
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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013