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| Sponsor: | Genentech |
|---|---|
| Information provided by (Responsible Party): | Genentech |
| ClinicalTrials.gov Identifier: | NCT01277302 |
Purpose
This study is a Phase IV multicenter randomized open-label study, with masking of the vision examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Edema |
Drug: ranibizumab |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Randomized Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion |
| Enrollment: | 199 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: ranibizumab
Randomized as needed ranibizumab 0.5 mg injection
|
| Experimental: B |
Drug: ranibizumab
Randomized monthly ranibizumab 0.5 mg injection
|
| Experimental: C |
Drug: ranibizumab
Non-randomized monthly ranibizumab 0.5 mg injection
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Ocular Inclusion Criteria (Study Eye)
Exclusion Criteria:
Ocular Exclusion Criteria (Study Eye)
Contacts and Locations
Show 43 Study Locations| Study Director: | Gary Sternberg, M.D. | Genentech |
More Information
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01277302 History of Changes |
| Other Study ID Numbers: | FVF4967g, ML01296 |
| Study First Received: | January 13, 2011 |
| Last Updated: | February 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Edema Macular Edema Retinal Vein Occlusion Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases |
Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |