Back to resultsBevacizumab for Central Retinal Vein Occlusion Study
Primary Purpose
Central Retinal Vein Occlusion
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
bevacizumab
Sham bevacizumab injection
Sponsored by
About this trial
This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring CRVO, anti-VEGF, Macular edema
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
Sites / Locations
- St Eriks Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Intravitreal bevacizumab
Sham injection
Arm Description
Outcomes
Primary Outcome Measures
The proportion of patients gaining 15 ETDRS letters or more
Secondary Outcome Measures
Change in foveal thickness
Cases of neovascular glaucoma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00906685
Brief Title
Bevacizumab for Central Retinal Vein Occlusion Study
Official Title
A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Kvanta
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion
Keywords
CRVO, anti-VEGF, Macular edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravitreal bevacizumab
Arm Type
Active Comparator
Arm Title
Sham injection
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
Intravitreal injection of 1.25 mg bevacizumab
Intervention Type
Drug
Intervention Name(s)
Sham bevacizumab injection
Intervention Description
Sham intravitreal injection
Primary Outcome Measure Information:
Title
The proportion of patients gaining 15 ETDRS letters or more
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in foveal thickness
Time Frame
6 months
Title
Cases of neovascular glaucoma
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Kvanta, MD, PhD
Organizational Affiliation
St Eriks Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Eriks Eye Hospital
City
Stockholm
ZIP/Postal Code
11282
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Bevacizumab for Central Retinal Vein Occlusion Study
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