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

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370851
First received: August 31, 2006
Last updated: November 23, 2009
Last verified: November 2009
History of Changes

August 31, 2006
November 23, 2009
August 2006
February 2008   (final data collection date for primary outcome measure)
  • Best corrected visual acuity [ Time Frame: At 12 week ] [ Designated as safety issue: Yes ]
  • Macular thickness by OCT [ Time Frame: At 12 week ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00370851 on ClinicalTrials.gov Archive Site
  • Need for macular photocuagulation [ Time Frame: At 12th week ] [ Designated as safety issue: Yes ]
  • Incidence of new vessel formation [ Time Frame: At 12th week ] [ Designated as safety issue: Yes ]
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Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Retinal Disease
Drug: Avastin (Bevacizumab)
Intravitreal injection of 125 mg Avastin
  • Experimental: 1
    Intravitreal injection of Avastin
    Intervention: Drug: Avastin (Bevacizumab)
  • Sham Comparator: 2
    Intervention: Drug: Avastin (Bevacizumab)
Moradian S, Faghihi H, Sadeghi B, Piri N, Ahmadieh H, Soheilian M, Dehghan MH, Azarmina M, Esfahani MR. Intravitreal bevacizumab vs. sham treatment in acute branch retinal vein occlusion with macular edema: results at 3 months (Report 1). Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):193-200. Epub 2010 Aug 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
June 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00370851
8532
Not Provided
Not Provided
Shaheed Beheshti Medical University
Not Provided
Principal Investigator: Siamak Moradian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shaheed Beheshti Medical University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP