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| Sponsor: | Genentech |
|---|---|
| Information provided by (Responsible Party): | Genentech |
| ClinicalTrials.gov Identifier: | NCT00891735 |
Purpose
This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with CNV secondary to AMD.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Drug: ranibizumab |
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, Double-Masked, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-Needed Basis (PRN) in Patients With Subfoveal Neovascular Age-Related Macular Degeneration |
| Enrollment: | 1095 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: ranibizumab
0.5 mg monthly intravitreal dose
|
| Experimental: 2 |
Drug: ranibizumab
2.0 mg monthly intravitreal dose
|
| Experimental: 3 |
Drug: ranibizumab
0.5 mg as needed intravitreal dose
|
| Experimental: 4 |
Drug: ranibizumab
2.0 mg as needed intravitreal dose
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Ocular Inclusion Criteria (Study Eye)
Exclusion Criteria:
Contacts and Locations
Show 99 Study Locations| Study Director: | Clinical Trials | Genentech |
More Information
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00891735 History of Changes |
| Other Study ID Numbers: | FVF4579g, GX01511 |
| Study First Received: | April 29, 2009 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Lucentis AMD Age-Related Macular Degeneration Subfoveal Neovascular Age-Related Macular Degeneration |
Wet AMD Macular degeneration Ranibizumab |
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |