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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00485836 |
Purpose
This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to central retinal vein occlusion (CRVO); 392 patients with CRVO were enrolled at 95 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Edema Retinal Vein Occlusion |
Drug: Sham injection Drug: Ranibizumab injection 0.3 mg Drug: Ranibizumab injection 0.5 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared With Sham in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion |
| Enrollment: | 392 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sham Comparator: Sham injection |
Drug: Sham injection
Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
Other Name: Lucentis
|
| Experimental: Ranibizumab injection 0.3 mg |
Drug: Ranibizumab injection 0.3 mg
Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
|
| Experimental: Ranibizumab injection 0.5 mg |
Drug: Ranibizumab injection 0.5 mg
Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Other Name: Lucentis
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Ocular Inclusion Criterion (Study Eye):
Exclusion Criteria:
Ocular Exclusion Criteria (Study Eye):
Contacts and Locations
More Information
| Responsible Party: | Disclosures Group, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00485836 History of Changes |
| Other Study ID Numbers: | FVF4166g |
| Study First Received: | June 11, 2007 |
| Results First Received: | August 16, 2010 |
| Last Updated: | February 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
CRVO RVO Lucentis Edema |
|
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 |