Central Retinal Vein Occlusion Clinical Trial
Official title:
A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
Verified date | November 2011 |
Source | St. Erik Eye Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | St Eriks Eye Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Anders Kvanta |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients gaining 15 ETDRS letters or more | 6 months | No | |
Secondary | Change in foveal thickness | 6 months | No | |
Secondary | Cases of neovascular glaucoma | 6 months | No |
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