Bevacizumab for Central Retinal Vein Occlusion Study

NCT ID: NCT00906685

Last Updated: 2011-11-22

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-09-30

Brief Summary

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Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.

Detailed Description

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Conditions

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Central Retinal Vein Occlusion

Keywords

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CRVO anti-VEGF Macular edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intravitreal bevacizumab

Group Type ACTIVE_COMPARATOR

bevacizumab

Intervention Type DRUG

Intravitreal injection of 1.25 mg bevacizumab

Sham injection

Group Type SHAM_COMPARATOR

Sham bevacizumab injection

Intervention Type DRUG

Sham intravitreal injection

Interventions

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bevacizumab

Intravitreal injection of 1.25 mg bevacizumab

Intervention Type DRUG

Sham bevacizumab injection

Sham intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CRVO with duration \< 6 months
* Visual acuity of 20/800 to 20/50

Exclusion Criteria

* CRVO with duration of \> 6 months
* previous treatment with anti-angiogenic drugs
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anders Kvanta

OTHER

Sponsor Role lead

Responsible Party

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Anders Kvanta

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anders Kvanta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St Eriks Eye Hospital

Locations

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St Eriks Eye Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ACRVO

Identifier Type: -

Identifier Source: org_study_id