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

NCT ID: NCT00370851

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Retinal Disease

Keywords

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intravitreal Avastin BRVO Macular edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Intravitreal injection of Avastin

Group Type EXPERIMENTAL

Avastin (Bevacizumab)

Intervention Type DRUG

Intravitreal injection of 125 mg Avastin

2

Group Type SHAM_COMPARATOR

Avastin (Bevacizumab)

Intervention Type DRUG

Intravitreal injection of 125 mg Avastin

Interventions

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Avastin (Bevacizumab)

Intravitreal injection of 125 mg Avastin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Siamak Moradian, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Siamak Moradian, MD

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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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. doi: 10.1007/s00417-010-1440-8. Epub 2010 Aug 18.

Reference Type DERIVED
PMID: 21337043 (View on PubMed)

Other Identifiers

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8532

Identifier Type: -

Identifier Source: org_study_id