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Completed

NCT Number: NCT00370851

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

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Key information

Conditions

Retinal Disease Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Siamak Moradian, MD

Tehran, Tehran Province, 16666, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avastin (Bevacizumab)

Drug

Intravitreal injection of 125 mg Avastin

Primary outcomes

  1. Best corrected visual acuity

    Time frame: At 12 week

  2. Macular thickness by OCT

    Time frame: At 12 week

Secondary outcomes

  1. Need for macular photocuagulation

    Time frame: At 12th week

  2. Incidence of new vessel formation

    Time frame: At 12th week

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 1, 2006
Registry last updated
Nov 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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