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Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370851
First Posted: September 1, 2006
Last Update Posted: November 25, 2009
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.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE

Condition Intervention Phase
Retinal Disease Drug: Avastin (Bevacizumab) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: At 12 week ]
  • Macular thickness by OCT [ Time Frame: At 12 week ]

Secondary Outcome Measures:
  • Need for macular photocuagulation [ Time Frame: At 12th week ]
  • Incidence of new vessel formation [ Time Frame: At 12th week ]

Enrollment: 82
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intravitreal injection of Avastin
Drug: Avastin (Bevacizumab)
Intravitreal injection of 125 mg Avastin
Sham Comparator: 2 Drug: Avastin (Bevacizumab)
Intravitreal injection of 125 mg Avastin

Detailed Description:
After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with acute BRVO with less than three month duration

Exclusion Criteria:

  • vision less than 20/320 and vison more than 20/50
  • duration more than 3 months
  • history of glaucoma and diabetic retinopathy
  • any media opacity that prevent funduscopy
  Contacts and Locations
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): NCT00370851


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00370851     History of Changes
Other Study ID Numbers: 8532
First Submitted: August 31, 2006
First Posted: September 1, 2006
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Shahid Beheshti University of Medical Sciences:
intravitreal Avastin
BRVO
Macular edema

Additional relevant MeSH terms:
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents