Status:
COMPLETED
An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)
Lead Sponsor:
Genentech, Inc.
Conditions:
Macular Edema
Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with...
Eligibility Criteria
Inclusion
- Signed informed consent form
- The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g)
- Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment
Exclusion
- History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study
- Concurrent use of systemic anti-VEGF agents
- Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye
- Use of intravitreal bevacizumab in the study eye and/or fellow eye
- Macular edema in the study eye due to other causes than RVO such as diabetes
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)
- Pregnancy or lactation
- Premenopausal women not using adequate contraception
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
- Current treatment for active systemic infection
- Inability to comply with study or follow-up procedures
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
608 Patients enrolled
Trial Details
Trial ID
NCT01442064
Start Date
July 1 2008
End Date
July 1 2010
Last Update
January 10 2012
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