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This is a Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to AMD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhuFab V2 (ranibizumab) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: The primary safety outcome measure is the incidence of SAEs (ocular and non ocular) evaluated through Month 12. | ||
| Cohort 2: The primary safety outcome measure is the incidence of SAEs (ocular and non-ocular) and AEs (ocular and non-ocular) evaluated through Month 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs (ocular and non-ocular) evaluated through Month 12 | ||
| Proportion of subjects who lose at least 15 letters in BCVA at Month 12 compared with baseline | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsontcho Ianchulev, M.D. | Genentech, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19643495 | Result | Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009 Sep;116(9):1731-9. doi: 10.1016/j.ophtha.2009.05.024. Epub 2009 Jul 29. |
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| Mean time to retreatment following the initial three monthly loading doses |
| Mean total number of injections through Month 12. |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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