Bevacizumab for Central Retinal Vein Occlusion Study

ID: NCT00906685
Status: Completed
Phase: Phase 3
Start Date: May 01, 2009
First Submitted: May 20, 2009
Last Updated: November 21, 2011
Results: N/A
Organization: St. Erik Eye Hospital
Sponsors & Collaborators: Anders Kvanta
Location: Sweden
Conditions: Central Retinal Vein Occlusion
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Study Description

Brief Summary

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

Condition or disease Intervention/treatment Phase

Central Retinal Vein Occlusion

Drug: bevacizumab
Other Names
Drug: Sham bevacizumab injection
Other Names
Phase 3

Tracking Information

First Submitted DateMay 20, 2009
Last Update Posted DateNovember 21, 2011
Start DateMay 01, 2009
Actual Completion DateSeptember 01, 2011
Primary Completion DateMarch 01, 2011
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • The proportion of patients gaining 15 ETDRS letters or more [Time Frame: 6 months]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Change in foveal thickness [Time Frame: 6 months]

  • Cases of neovascular glaucoma [Time Frame: 6 months]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleBevacizumab for Central Retinal Vein Occlusion Study
Official TitleA Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
Brief Summary

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

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
60
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Central Retinal Vein Occlusion
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: bevacizumab

Intravitreal injection of 1.25 mg bevacizumab

Other Names
Drug: Sham bevacizumab injection

Sham intravitreal injection

Other Names
Study Groups/Cohorts
Intravitreal bevacizumab

Sham injection

Study Arms
Active Comparator Intravitreal bevacizumab
Drug : bevacizumab
Intravitreal injection of 1.25 mg bevacizumab

Sham Comparator Sham injection
Drug : Sham bevacizumab injection
Sham intravitreal injection

Arm Intervention/Treatment
Active Comparator Intravitreal bevacizumab
Drug : bevacizumab
Sham Comparator Sham injection
Drug : Sham bevacizumab injection

Recruitment Information

Recruitment Status:Completed
Enrollment60
Completion DateSeptember 01, 2011
Eligibility Criteria: 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
GenderAll
Age N/A to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Sweden

Administrative Information

NCT Number:NCT00906685
Other Study ID Numbers
ACRVO
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyAnders Kvanta, St. Erik Eye Hospital
Study Sponsor
Anders Kvanta
Collaborators
Not Available
Investigators
Principal Investigator
Anders Kvanta, MD, PhD
St Eriks Eye Hospital